Jobs
Interviews

251 Clinical Data Jobs - Page 2

Setup a job Alert
JobPe aggregates results for easy application access, but you actually apply on the job portal directly.

1.0 - 6.0 years

2 - 6 Lacs

Agra

Work from Office

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Posted 1 week ago

Apply

0.0 - 2.0 years

2 - 4 Lacs

Kochi, Bengaluru

Work from Office

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that dont require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team." Qualifications Bachelors Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Posted 1 week ago

Apply

3.0 - 8.0 years

5 - 10 Lacs

Thane

Work from Office

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable 24 hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req Two (2) years of pharma experience Pref Sound knowledge of Medicine In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of Pharmacovigilance- ICSR and Aggregate reports In-depth knowledge of departmental standard operating procedures (SOPs) Skill in use of multiple safety databases Adequate Computer skills, especially Microsoft word, excel & PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

Posted 1 week ago

Apply

4.0 - 7.0 years

6 - 9 Lacs

Chennai, Thiruvananthapuram

Work from Office

Senior Statistical Programmer II (DMC) - Office or Home - India ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Statistical Programmer I to join our diverse and dynamic team. As a Senior Statistical Programmer I at ICON, you will play a crucial role in analyzing clinical trial data and supporting the statistical analysis process to ensure high-quality results. You will contribute to the success of our clinical studies by developing and validating statistical programs, collaborating with biostatisticians, and ensuring compliance with regulatory standards. What You Will Be Doing: Developing and validating SAS programs for statistical analysis and reporting of clinical trial data. Collaborating with biostatisticians to define analysis plans and statistical methods to be applied to clinical data. Performing quality control checks on statistical outputs and ensuring accuracy and consistency in reporting. Assisting in the preparation of statistical reports, presentations, and publications for regulatory submissions. Contributing to process improvements by identifying efficiencies in programming practices and methodologies. Your Profile: Bachelor s or Master s degree in Statistics, Mathematics, Computer Science, or a related field. Experience in statistical programming, preferably in a clinical research or pharmaceutical setting. Strong proficiency in SAS programming, with a solid understanding of statistical concepts and methodologies. Excellent analytical and problem-solving skills, with a keen attention to detail. Strong communication skills, with the ability to work collaboratively in a team environment and effectively convey complex information. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Posted 1 week ago

Apply

1.0 - 6.0 years

2 - 6 Lacs

Visakhapatnam

Work from Office

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Posted 1 week ago

Apply

1.0 - 6.0 years

2 - 6 Lacs

Faridabad

Work from Office

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Posted 1 week ago

Apply

1.0 - 6.0 years

2 - 6 Lacs

Chandigarh

Work from Office

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Posted 1 week ago

Apply

1.0 - 6.0 years

2 - 6 Lacs

Jaipur

Work from Office

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Posted 1 week ago

Apply

1.0 - 6.0 years

2 - 6 Lacs

Surat

Work from Office

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Posted 1 week ago

Apply

1.0 - 6.0 years

2 - 6 Lacs

Kochi

Work from Office

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Posted 1 week ago

Apply

0.0 - 2.0 years

2 - 6 Lacs

Kochi, Bengaluru

Work from Office

Job Overview Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that dont require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team." Qualifications Bachelors Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Posted 1 week ago

Apply

15.0 - 20.0 years

30 - 37 Lacs

Bengaluru

Work from Office

Job Description Summary As part of the Science and Technology Organization, we develop the services that drive the next generation of healthcare applications and enable developers to build new and innovative solutions that seamlessly span clinical devices & sensors, local compute and storage hubs, and a global footprint of cloud resources. We are looking for a talented and creative expert to help define, create and evolve a new generation of world-class cloud-based healthcare solutions & AI applications across our business portfolios powered by hundreds of existing and new purpose-built services. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities Work backwards from customers to define the strategy for one of our leading digital AI products. Identify target user personas and markets for integration of applications and AI into customer workflows. Clearly articulate value-propositions to drive adoption and relevance. Build cost/pricing models, partner vs build vs buy strategy. Work closely with customers, architects, engineers, and external vendors to prioritize deliverables and ensure releases meet roadmap content and timelines. Work with cross-functional teams to innovate and change the way software is deployed and commercialized to rapidly bring to market new solutions that help unlock, correlate, and analyze the clinical data that powers todays intelligent, precision healthcare. Be equally comfortable digging into business and commercial requirements and digging into operational and deployment strategies with service, architecture and design teams Be flexible, excel when faced with ambiguity and thrive in a fast-paced environment. Have a bias for acting now - then iterate. Required Qualifications Bachelors degree in Engineering, Computer Science or related field 15+ years of managing and/or activating products in a related industry including hands-on management of large, cross-functional software and system efforts Proven experience in identifying customer s business and strategic needs, concerns, and desires to drive value-adding product capabilities Desired Characteristics Master s Degree in Engineering, Computer Science or related field 5+ years of hands-on software engineering experience Experience leading and/or managing efforts in a distributed systems environment Hands-on experience with Service-Oriented Architecture (SOA) and Cloud solutions Familiarity with Healthcare workflows and deployment scenarios Real world experience with portfolio and investment decisions to balance customer needs, existing product requirements and long term enterprise differentiation Strong written and verbal communication skills Ability to excel in a fast-paced, startup-like environment GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. #LI-RS1 #Hybrid Relocation Assistance Provided: Yes

Posted 1 week ago

Apply

3.0 - 9.0 years

20 - 25 Lacs

Kochi

Work from Office

Job Overview Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product s safety profile Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Represent safety and clinical data review findings during client meetings Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies Provide medical oversight for label development, review and change Provide medical support and attendance at Data Safety Monitoring Board Meetings Attends and contributes medical safety evaluation on Safety Monitoring Committees Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture. Act as Global Safety Physician or Assistant or Back-up on projects as assigned Attend project meetings, medical safety team meetings, and client meetings as requested Ensure coverage for all medical safety deliverables within regulatory or contracted timelines Provide medical escalation support for medical information projects Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects 24 hour medical support as required on assigned projects Maintain awareness of medical-safety-regulatory industry developments Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice Knowledge of clinical trials and pharmaceutical research process Ability to establish and meet priorities, deadlines, and objectives. Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

Posted 1 week ago

Apply

4.0 - 7.0 years

15 - 17 Lacs

Chennai, Thiruvananthapuram

Work from Office

Senior Statistical Programmer II (DMC) - Office or Home - India We are currently seeking a Senior Statistical Programmer I to join our diverse and dynamic team. As a Senior Statistical Programmer I at ICON, you will play a crucial role in analyzing clinical trial data and supporting the statistical analysis process to ensure high-quality results. You will contribute to the success of our clinical studies by developing and validating statistical programs, collaborating with biostatisticians, and ensuring compliance with regulatory standards. What You Will Be Doing: Developing and validating SAS programs for statistical analysis and reporting of clinical trial data. Collaborating with biostatisticians to define analysis plans and statistical methods to be applied to clinical data. Performing quality control checks on statistical outputs and ensuring accuracy and consistency in reporting. Assisting in the preparation of statistical reports, presentations, and publications for regulatory submissions. Contributing to process improvements by identifying efficiencies in programming practices and methodologies. Your Profile: Bachelor s or Master s degree in Statistics, Mathematics, Computer Science, or a related field. Experience in statistical programming, preferably in a clinical research or pharmaceutical setting. Strong proficiency in SAS programming, with a solid understanding of statistical concepts and methodologies. Excellent analytical and problem-solving skills, with a keen attention to detail. Strong communication skills, with the ability to work collaboratively in a team environment and effectively convey complex information. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Posted 1 week ago

Apply

3.0 - 8.0 years

6 - 10 Lacs

Thane

Work from Office

Job Overview The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product s safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable Provide aggregate reviews of safety information, including but not limited to clinical data, postmarketing, literature review and observational studies to maintain oversight of a product s safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc) Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment. Ensure update of watch list, list of expectednsess, labeling list/RSIs etc for the assigned products and develop such additional capabilities within the team Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable 24 hour medical support as required on assigned projects Maintain awareness of medical safety-regulatory industry developments Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req Two (2) years of pharma experience Pref Sound knowledge of Medicine In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of Pharmacovigilance- ICSR and Aggregate reports In-depth knowledge of departmental standard operating procedures (SOPs) Skill in use of multiple safety databases Adequate Computer skills, especially Microsoft word, excel & PowerPoint Good communication skills- verbal and written Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients and regulatory agency representatives Ability to establish and maintain effective working relationships with coworkers, managers and clients A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Posted 1 week ago

Apply

5.0 - 10.0 years

6 - 16 Lacs

Bengaluru

Work from Office

Hiring for Clinical Data Manager | Bangalore | Hybrid (3 days in a week) Exp : 5 + yrs Job at Bangalore (Hybrid) immediate to 15 days max Education & Experience 5+ years experience in Clinical Data Management preferred. Bachelors degree in a health-related field or equivalent experience preferred. CCDM Certification preferred. Professional Skills Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems. Strong analytical and strategic thinking skills Detail oriented, ability to multitask with strong prioritization, planning and organization skills. Excellent collaborative skills Demonstrated command of the English language with proficiency in both verbal and written communication Technical Skills Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology Proficient with EDC and Clinical Data Management Systems Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred. Experience with RBQM methodology preferred. Exposure to CDISC guidelines and standards If interested please share your resume to rathna@trinityconsulting.asia with below details : Name : Mobile number : Total Experience : Clinical data manager Experience : CTC : ECTC: Notice Period : Last working date : Current Location : will you relocate to Bangalore :

Posted 1 week ago

Apply

1.0 - 3.0 years

5 - 8 Lacs

Mumbai

Work from Office

SUMMARY The Data Collector will support the implementation of an AI-driven dermatology screening project at AIIMS Delhi OPD. The role involves assisting dermatologists and research staff by collecting patient demographic and clinical data, capturing high-quality diagnostic images of skin conditions using mobile based applications, ensuring accurate data entry, and coordinating with patients for follow-up documentation. This role is crucial for ensuring data quality for training and validating the AI system. Location - Delhi ABOUT US - https://www.wadhwaniai.org/ Wadhwani AI is a nonprofit institute building and deploying applied AI solutions to solve critical issues in public health, agriculture, education, and urban development in underserved communities in the global south. We collaborate with governments, social sector organizations, academic and research institutions, and domain experts to identify real-world problems, and develop practical AI solutions to tackle these issues with the aim of making a substantial positive impact. We have over 30+ AI projects supported by leading philanthropies such as Bill & Melinda Gates Foundation, USAID and Google.org. With a team of over 200 professionals, our expertise encompasses AI/ML research and innovation, software engineering, domain knowledge, design and user research. In the Press: Our Founder Donors are among the Top 100 AI Influencers G20 India s Presidency: AI Healthcare, Agriculture, & Education Solutions Showcased Globally. Unlocking the potentials of AI in Public Health Wadhwani AI Takes an Impact-First Approach to Applying Artificial Intelligence - data.org Winner of the H&M Foundation Global Change Award 2022 Sole Indian Winners of the 2019 Google AI Impact Challenge, and the first in the Asia Pacific to host Google Fellows Cultures page of Wadhwani AI - https: / / www.wadhwaniai.org / culture / ROLES AND RESPONSIBILITIES Collect demographic and clinical details from consenting OPD patients using project tools. Capture high-resolution skin images as per defined protocols using handheld/mobile devices. Assist patients in navigating the image capture and consent process. Upload collected data into the project software and ensure completeness and accuracy. Label and annotate data as instructed by the research team. Coordinate with dermatologists, nursing staff, and project investigators to support smoothworkflow in OPD. Maintain confidentiality and ethical standards while handling patient data. Report daily activity logs and escalate any technical issues or patient concerns. Assist in training sessions, audits, or evaluations of data quality as required. REQUIREMENTS Minimum qualification: Bachelors degree in life sciences, nursing, allied health, or any related field. Basic computer proficiency, especially in using tablets, mobile apps, and data entry forms. Experience in clinical data collection or working in a hospital/research setting is desirable. Familiarity with handling diagnostic equipment or medical photography is an advantage. Good communication skills in English and Hindi to interact with patients and staff. Ability to work in a fast-paced OPD environment with minimal supervision. Attention to detail and a commitment to accuracy and confidentiality. We are committed to promoting diversity and the principle of equal employment opportunity for all our employees and encourage qualified candidates to apply irrespective of religion or belief, ethnic or social background, gender, gender identity, and disability.

Posted 1 week ago

Apply

1.0 - 5.0 years

3 - 7 Lacs

Hyderabad

Work from Office

Clinztech is looking for Clinical Data Analyst I to join our dynamic team and embark on a rewarding career journey. Managing master data, including creation, updates, and deletion. Managing users and user roles. Provide quality assurance of imported data, working with quality assurance analysts if necessary. Commissioning and decommissioning of data sets. Processing confidential data and information according to guidelines. Helping develop reports and analysis. Managing and designing the reporting environment, including data sources, security, and metadata. Supporting the data warehouse in identifying and revising reporting requirements. Supporting initiatives for data integrity and normalization. Assessing tests and implementing new or upgraded software and assisting with strategic decisions on new systems. Generating reports from single or multiple systems. Troubleshooting the reporting database environment and reports. Evaluating changes and updates to source production systems. Training end - users on new reports and dashboards. Providing technical expertise in data storage structures, data mining, and data cleansing.

Posted 1 week ago

Apply

1.0 - 3.0 years

2 - 6 Lacs

Bengaluru

Work from Office

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Associate Qualifications: BE/BTech Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Database Management team is committed to developing and maintaining databases for clinical trials, which includes creating Case Report Forms (CRFs) and developing Edit and Validation Checks using programming skills like C# and PL/SQL. They also support data integration from various external sources such as labs and Interactive Response Technology (IRT). The team ensures compliance with regulatory standards and guidelines, maintaining high levels of data quality and security. Additionally, they continuously seek to improve database processes and tools by leveraging the latest technologies and best practices to enhance efficiency and accuracyDevelop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for Clinical Database ProgrammingClinical Data ManagementSAS ClinicalAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAbility to establish strong client relationshipAgility for quick learningOracle Procedural Language Extensions to SQL (PLSQL)Structured Query Language (SQL)C, C++, C# Programming SkillsExperience in writing programs using Javascript Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BE,BTech

Posted 1 week ago

Apply

3.0 - 8.0 years

8 - 10 Lacs

Thane, Mumbai (All Areas)

Work from Office

Were looking for a Project Manager to lead clinical data augmentation initiatives that enable better risk identification and proactive health management for insured populations. The ideal candidate will have a strong understanding of clinical data, governance, and healthcare processes, and will work cross-functionally to improve data flow and accuracy. Key Responsibilities: Lead and manage multiple clinical data augmentation projects. Ensure seamless data flow from core to peripheral systems. Identify new health data sources to improve risk stratification. Collaborate with cross-functional teams to automate reporting and reduce discrepancies. Maintain data recency to support health assurance transformation goals. Prepare for transition into a clinical data analysis-focused role.

Posted 1 week ago

Apply

2.0 - 6.0 years

9 - 10 Lacs

Hyderabad

Work from Office

Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. These tasks are to be performed independently or team based with minimal guidance and supervision. About the Role 1. Drive the implementation of data analytics reports and dashboards for optimal data review by working with the users to establish robust user specifications and with programmers to implement the optimal output. 2. Translate business requirements into logical models and provide direction to the development team to translate business logic. 3. Lead authoring of the user requirements document, functional specifications and functional testing scripts 4. Proactively identify or address needs for optimal data review working with users and programmers as appropriate. 5. Implement and execute robust project plans for delivery, ensuring customer needs are addressed in a timely manner, 6. Provide coordination between the project resources so that deadlines are met on deliverables. 7. Drive development of appropriate user training. Drive all necessary change management activities related to implementation of new data review tools / reports as related to data cleaning, review and visualization. 8. Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. 9. Provide quantitative analytical support to the global program teams, including providing support on analyzing reports and defining KPI Metrics. 10. Systematically sample / monitor utilization of reports and tools, perform and coordinate periodic review of outputs. Report findings and take necessary steps to ensure reports are being used for optimal data review via Metrics. 11. Create, file and maintain appropriate documentation 12. Work with the internal SMEs and key stakeholders in providing analysis and interpretation of clinical program/trial operational data. 13. Lead initiatives within Analytics, including training, to support overall compliance and adherence to data review through robust reports and tools. 14. Proactively identify and address areas of concerns to avoid issues and ensure consistency, accuracy and completeness of reported clinical data. 15. Support or lead special projects of limited scope (sub team lead, local project, etc. ) both clinical and non-clinical in nature. Provide study level expertise and involvement in CTTs and on GPTs for small projects. 16. May assist manager in coordinating and directing Clinical Reporting activities of External Partners (Contingent Workers, Functional Service Providers, Interns, etc. ) 17. Program reports of advanced complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, C#, VB script, SAS, Python, R. 18. Demonstrated experience in the concepts and use of Clinical Data Standards (e. g. SDTM, Novartis standard) for creation of report specifications or reports output. 19. Lead special projects both clinical and non-clinical in nature or in general areas spanning various responsibilities but not limited to systems issues, processes, user support, training, etc.

Posted 1 week ago

Apply

6.0 - 11.0 years

25 - 30 Lacs

Hyderabad

Work from Office

Lead scientific engagement with their Medical Experts. Implement clinical and educational strategies and respond to unsolicited medical enquiries. Key Responsibilities Build and maintain scientific relationships with Medical Experts to support strategic engagement. Identify and map key accounts and experts aligned with medical priorities. Develop and execute engagement plans tailored to country-specific strategies. Respond to unsolicited medical inquiries with accurate, up-to-date scientific information. Support clinical trial execution and site education in collaboration with clinical operations. Facilitate Investigator Initiated Trial (IIT) processes upon investigator request. Act as a scientific resource for internal field teams and cross-functional partners. Ensure timely reporting of adverse events and technical product complaints. Essential Requirements Proven experience in operations management and cross-functional collaboration. Strong understanding of clinical research and medical affairs processes. Proficiency in scientific communication, including medical writing and data interpretation. Familiarity with CRM tools and digital platforms for stakeholder engagement. Knowledge of disease management, drug development, and epidemiology. Ability to analyze and present clinical data effectively. Fluency in English, both written and spoken. Desirable Requirements Prior experience in a Medical Scientific Liaison or similar field-based medical role. Advanced degree in life sciences (e. g. , MD, PhD, PharmD) preferred.

Posted 1 week ago

Apply

7.0 - 12.0 years

10 - 18 Lacs

Noida

Work from Office

At MetLife, we seek to make a meaningful impact in the lives of our customers and our communities. The Global Technology & Operations group (GTO) is a diverse team of engineers, developers, business analysts, claims analysts and project managers with the freedom to create innovative and solutions to address core business challenges with MetLife. This role will work with claimants, physicians, employers, and customers to ensure strict adherence in determining functional abilities. Provides recommendations regarding claimants current/potential functional abilities and develops goal-focused return-to-work plans. To apply, Call HR Nikita Grover at 8800307658 Job Responsibilities Provides professional medical, technical, consulting advice, and recommendations in support of claims evaluation, investigation, and assessment for various claims-related departments, while managing assigned caseload of complex case applying specialized training and knowledge to the assessment of cases and acting as a resource on clinical and technical issues. Conducts complex research, review and analysis of medical records, treatment plans and claim information. Provides recommendations regarding claimants current potential functional abilities and develops goal-focused return-to-work plans. Assess training needs and creates, authors, and presents medical training to claim and business partner associates. Engages claimants, healthcare providers, employers, and customers to ensure strict adherence in determining functional abilities. Engages claimants, health care providers and employers in return to work potential and planning while coaching claim specialists on identifying and acting upon return-to-work potential. Creates effective requests for medical information which focus on clarifying medical restrictions and limitations and their impact on work functionality. Performs other related duties as assigned or required Education, Technical Skills & Other Critical Requirement Bachelors degree (Medical) or diploma with a minimum of 15 years of education. Experience Current RN licensure 4+ years of experience as an RN with Clinical/Ops Experience Preferred 7+ years Disability claims and/or clinical experience. Disability claims experience Preferred designations CCM (certified case management) and/or CDMS (certified disability management specialist).

Posted 1 week ago

Apply

0.0 - 5.0 years

35 - 40 Lacs

Moradabad

Work from Office

Interventional Radiologist Location: Moradabad Department: Radiology Hospital Summary: The Siddh Multispeciality Hospital is established by Dr. Anurag Mehrotra, MD, DM, FACC, FESC a renowned figure in the field of cardiology for last twenty years. We have been able to achieve NABH (Complete) & ISQUA (For International Patients) Accreditations in short span of time. Hospital also got accreditation with NBEMS for DNB courses. Siddh Hospital is tertiary Care hospital known for its cardiac & intensive care. Hospital also excess in equipped departments like gastro surgery, minimal invasive surgery, ortho & neurosurgery, maternity care, paediatrics, nephrology and others. Job Summary: We are seeking a skilled and experienced Interventional Radiologist to join our multidisciplinary medical team. The role involves performing minimally invasive, image-guided diagnostic and therapeutic procedures using advanced radiological technology. The Interventional Radiologist will collaborate closely with clinicians from various specialties to provide precise, patient-centric care and contribute to improved clinical outcomes. The ideal candidate should have strong expertise in vascular and non-vascular procedures, excellent imaging interpretation skills, and a commitment to high standards of patient safety and procedural excellence. Key Responsibilities: 1. Perform Image-Guided Procedures 2. Clinical Assessment & Case Planning 3. Patient Counselling & Consent 4. Post-Procedural Care & Follow-up 5. Collaboration with Multidisciplinary Teams 6. Imaging Interpretation 7. Infection Control & Radiation Safety 8. Training & Education 9. Equipment Management 10. Documentation & Reporting Qualifications & Skills: Educational Requirements MBBS from a recognized medical institution. MD/DNB in Radiology or equivalent postgraduate degree. Fellowship or DM in Interventional Radiology (preferred or required depending on institution). Proficient in performing a wide range of minimally invasive, image-guided procedures. Skilled in operating and interpreting CT, MRI, fluoroscopy, and ultrasound. Strong ability to interpret complex imaging studies and integrate clinical data. Accurate decision-making in procedure planning and intra-procedural judgment. Salary: As per industry standards Work Type: Full-time Salary Package: Competitive salary, Paid time off, and comprehensive benefits package. For . Please include Hospital Marketing Manager Application [Your Name] in the subject line. Contact: HR Department Siddh Multi Speciality Hospital Kanth Road, Harthala Industrial Estate, Moradabad, U.P. - 244001 +91 63968 52016

Posted 1 week ago

Apply

2.0 - 5.0 years

5 - 9 Lacs

Bengaluru

Work from Office

Provides DM leadership across assigned trial(s) (4 or more) . Acts as the Trial Data Manager where needed for 3-4 studies in parallel. Demonstrates a business understanding of the portfolio, products and indication to identify and assist in successful application of data management processes Provides feedback to assure well- written protocols. Recognize and resolve protocol issues that may impact database design, data validation, data integrity and/or analysis/reporting while making the best use of standards and best practices Leads the team through database build requirements, timelines and complete startup activities for study including : building the eCRF , completion guidelines , standard and simple rules, data validation plan and user acceptance testing (UAT) Set up and manage s external data in accordance with protocol requirements, process and validation requirements Performs DM maintenance and validation activities during the study timely and with quality. Tracks and reports status and progress for assigned trials and projects. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks). Effectively communicates status updates and study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM) Responsible and accountable to ensure consistency of assigned trials with program level standards through technical implementation of Industry (CDISC and regulatory) Data Standards, providing support to business users and teams on their use and supporting the implementation of the Clinical Data Standards strategy. Mentors and assists Junior team members. Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence Ensures adherence to GCP, DM standards, SOPs/procedures, job aids and guidelines Maintain up-to- date, knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards ( e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines. ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker

Posted 1 week ago

Apply
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

Featured Companies