119 Clinical Operations Jobs - Page 4

Role & responsibilities MIS and Reporting: Maintain and update the Clinical Management Information System (MIS). Generate and circulate daily, weekly, and monthly operational reports to internal stakeholders. Ensure data accuracy and timely reporting. Coordination with Doctors: Liaise and coordinate with doctors and clinical partners across India for scheduling, documentation, and operational requirements. Act as a point of contact for communication between internal teams and external medical professionals. Payment & Invoice Processing: Handle the end-to-end process for clinical invoice validation and payment processing. Maintain payment trackers and coordinate with the finance team for timely disbursements. KOL Coordination: Support the planning and execution of KOL-related initiatives including meetings, events, and collaborations. Maintain an updated database of KOLs and ensure effective engagement. Licensing & Compliance: Oversee the renewal and documentation of all clinical licenses. Ensure 100% compliance with PCPNDT regulations and maintain proper records. Stakeholder Communication: Prepare and share daily operational updates with leadership and cross-functional teams. Address queries and provide operational insights as needed. Qualifications: Bachelors degree in Healthcare Administration, Life Sciences, Business Administration, or a related field (Masters degree is a plus). 2–5 years of experience in clinical operations or healthcare administration. Familiarity with clinical compliance frameworks, especially PCPNDT. Strong knowledge of Excel and MIS tools; proficiency in data handling and reporting. Excellent communication, coordination, and interpersonal skills. Ability to multitask and manage stakeholders across geographies. Key Competencies: High attention to detail and data accuracy Stakeholder management Time and process management Problem-solving and adaptability Compliance and documentation proficiency

Should have Strong Knowledge in medical review of ICSRs and Pharmacovigilance Knowledge of safety databases, such as Argus, ARISg. Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B). Required Candidate profile Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature. BDS and MBBS Are eligible to apply

Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Minimum Bachelor's or Masters degree in related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Are Applicable to Apply

Role & responsibilities: Ensures that qualified by education, training, and experience to assume responsibility for the proper conduct of the clinical studies. Maintaining current, up-to-date curriculum vitae . Assuming responsibility for the conduct of the clinical investigation. Signing the protocol Documenting the financial aspects of the trial. Disclosing conflicts of interest as described in the regulations. Ensuring adequate number of qualified staff and adequate facilities for conductance of the study properly and safely. Ensures that all persons assisting with the study are adequately informed about the protocol, the investigational product(s), and their study-related duties and functions. Ensuring that medical care is provided to a subject for any adverse event(s) that is reported. Informing a subject when medical care is needed to treat an inter-current illness. Provide information regarding adverse events and serious adverse events to the IRB/IEC. Possessing a thorough understanding of the requirements of each protocol . Ensuring recruitment goals are reasonable and attainable. Assessing overall protocol feasibility. Following the trials randomization procedures. Ensuring that the informed consent form contains the entire Essential and additional elements required. Conduct of the clinical studies specified by the applicable regulatory requirement(s), the IRB/IEC requirements and/or the regulatory authorities. Conduct the study as per the principles of ethics and is compliance with Good Clinical Practices (GCP). Attending education workshops. Reviewing professional publications. Participating in professional societies Maintaining a list of qualified persons and their corresponding trial-related delegated duties. Preferred candidate profile can send to email: hr@qpsbioserve.com or raghavendra.kundhula@qpsbioserve.com Perks and benefits: Nil

Roles and Responsibilities Clinical Pharmacy Manager with a demonstrated history of working in the hospital & health care industry. Skilled in Pharmacy operations, JCI & NABH accreditations, Pharmacovigilance, Healthcare Management, Medicine, Clinical Pharmacy, Policy Management and Adverse Event Reporting. Strong healthcare services professional with a Master of Pharmacy (M. Pharma), focused in Hospital Pharmacy (Operations & Clinical) Supervise pharmacy operations, ensuring accurate dispensing of medications and adherence to pharmaceutical regulations. Oversee pharmacy staff, including pharmacists and technicians, providing guidance and training. Ensure compliance with local & state pharmacy laws and regulations. Manage medication inventory, procurement, and storage to prevent shortages or wastage. Implement policies for safe medication handling, storage, and disposal. Provide consultation to patients regarding prescriptions, dosage, and potential side effects. Collaborate with healthcare professionals to optimize medication therapy management. Monitor financial performance, budgeting, and cost control measures for the pharmacy. Preferred candidate profile Bachelor's or Master's degree in Pharmacy/ Healthcare Administration Proven experience in clinic and pharmacy management. Strong leadership and organizational skills. Excellent communication and interpersonal abilities. Knowledge of healthcare regulations, insurance policies, and pharmaceutical guidelines. Ability to handle administrative tasks, including budgeting, staffing, and performance evaluations. Interested candidates can their resume to Career@group-108.com

Key Responsibilities: Daily Operations Management Client Experience Team Coordination Sales & Targets Oversight Inventory & Asset Monitoring Reporting & Communication

RoleClinical & Therapy Development Manager Type Full Time Job description - Successfully complete our internal training plan to include hemodynamics, ECG, angiography, echo CT imaging modalities and complete the case support and proctor delegate authorizations. - Provide active commercial case support, demonstrating excellence in procedural success rates patient outcomes. - Scrub in sterile and provide TAVI valve loading in procedures training instruction to trial and commercial customers - Provide our customers CT valve sizing analysis utilizing the Pie Medical 3Mensio CT program - Lead customer didactic education sessions for account activation before first implants - Lead pre case planning debriefing of heart team pre post procedure and provide ongoing education as requested for proper in - service levels - Provide documentation as required for quality assurance initiatives - Co-develop commercial business plan for assigned region - Co-support internal/external quarterly business reviews - Data entry into Salesforce, Mentor software for customer case support management - Learn commercial data analytics, resources tools for effective customer experience - Support customer engagement strategy with Marketing team (TM)) - Demonstrate competency with marketing messaging, clinical evidence and medical education portfolio offering - Demonstrate knowledge in the TAVI market, industry competitive insights - Participate in team meetings, conventions, and national sales meetings as requested - Drive innovative marketing and referral activities in collaboration with the markeitng team - Collaborate with the Sales and marketing team to conduct targeted market development in India Sub-continent. - Lead organization and delivery of key symposia by supporting discussions with customers to define agenda topics, select appropriate speakers / chairs, create required materials for events. - Develop Key Opinion Leaders within this segment to create market for the new therapies which will be launched and create advocates for your product who will speak on various forums - Identify high potential international / national referral community meetings to target for market development and collaborates with sales management team to put forward case for investment (program contributions / symposiums / workshops) This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Handling front Office

Fresher Hiring 2023 - 2025 Passouts only - All India Qualification - B.Pharm, M.Pharm, B.SC, M.SC, Life Sciences Graduates & Post Graduates Medical - BDS, BHMS, BAMS, MBBS Role & responsibilities Perform data reconciliation between different data sources and study documents to ensure data integrity and consistency across datasets. Generate data queries to address discrepancies, inconsistencies, and missing data identified during data review, ensuring timely resolution and documentation of data queries Communicate data queries to investigative sites, data managers, and study personnel, following up on query responses and resolving discrepancies in collaboration with relevant stakeholders Identify deviations from protocol-specified procedures, eligibility criteria, and data collection guidelines, escalating issues to appropriate personnel for resolution Perform quality checks and data validation procedures to ensure accuracy, consistency, and reliability of clinical trial data, adhering to data management standards and industry best practices Assist in the development and implementation of data validation plans, data review guidelines, and quality control procedures to maintain high standards of data quality and integrity. Assist in a variety of specialties including but not limited to primary care, orthopedics, rheumatology, etc. Updates patient history, physical exam, and other pertinent health information in the document as required. Complies with Compliance standards of the Organization as laid by HIPAA. Performs other duties and tasks to improve provider productivity and workflow as assigned by supervisors. Assist documenting the patients, electronic health record (EHR). Fresher Hiring - Pharma / Life Sciences / Medical Qualification - B.Pharm, M.Pharm, B.SC, M.SC, Life Sciences Graduates & Post Graduates Medical - BDS, BHMS, BAMS, MBBS Location - All India - Delhi, Mumbai, Pune, Bangalore, Kochi, Chennai, Hyderabad, Ahmedabad, Bhopal, Indore, Kolkata, Chandigarh

Summary -To plan and lead Category initiatives for a clearly defined sub-category globally OR one category regionally OR all categories in one country OR multiple cross-divisional categories in one country; to develop the sub-category strategy as part of the wider Category Strategy; to lead proactive sourcing projects, specification definition and demand management, as we'll as manage sub-category-specific supplier performance and innovation activities. About the Role Position Title: Global Category Manager, Clinical RD Location : Hyd-india #LI Hybrid Job Purpose: The Global Category Manager, responsible to manage Clinical functional services Categories in space of Data Management, Statistical Programming, Trial Monitoring, Regulatory, Pharmacovigilance Medical Writing, plans and leads all strategic Procurement activities within the assigned categories, at a global level and develops proposals for strategic sourcing decisions. The role provides high value procurement solutions to the business and category strategies; supports third party vendor selection, vendor development, technology management and supplier performance measurement activities. The Global Procurement Category Manager ensures best-in-class delivery of external services in support of functions and to realize year-on-year productivity improvements, cost savings, and process improvements working in close collaboration with Business Stakeholders. Your responsibilities include but not limited to: The role is responsible for all Novartis Global spend for assigned Global Clinical Operations functions . These services have FSP long term engagements with goals for value creation and continuous improvement. Specifically, you will be responsible to develop sourcing strategies for clinical study delivery supporting Novartis development pipeline. Establish strategic category plans tailored to assigned categories/sub-categories, in congruence with organizational objectives. Lead the sourcing, negotiation and contracting to leverage buying power and recommend appropriate Procurement strategies and tactics to obtain desired results Support/Lead the design and implementation of executive governance around preferred suppliers the objective of which is to ensure performance delivery, continuous improvement, and access to innovation from supplier arrangements to achieve value contribution targets on a global basis Negotiate complex Commercial Terms and masterservices Agreements working collaboratively with Business Stakeholders, Legal, Data Privacy and Supplier Quality Accountable for a proportion of the overall Clinical category savings target and leads proactive category projects, spanning sourcing projects, demand management and process improvement, as we'll as managing sub-category specific supplier performance and innovation activities to support the delivery of the global procurement targets. Provide financial and business analysis (eg Data mining of supplier spend from Procurement and Financial Systems, output analysis and interpretation), supporting global market intelligence in the category area and acting as the focal point for category subject matter expertise to the global business and procurement community. Support in the indirect management of Clinical Sourcing Managers by assisting in their quarterly and year end reviews, provide support in establishing their goals within the category and assist in their development. Essential Requirements: Successful project execution by providing all external solutions in time / at the required quality / within budget as verified by the business. Value Delivery - optimized Total Cost of Ownership and cost productivity/savings in compliance with approved Novartis Finance Productivity guideline. Successful and measurable execution on efficiency programs Measurable and continuous process improvement compliance assurance. Understanding the Procurement KPIs related to market insights, price and demand development as we'll as procurements performance. Compliance with all GxP relevant processes Strong project management and/or other leadership experience. Knowledge of Global RD Clinical CRO market What you'll bring to the role: masters Degree/other advanced degree in Lifesciences or Pharmaceutical sciences MBA degree is preferred A minimum of 12 years Core experience in strategic negotiations, alliances, and operations in RD at a pharmaceutical company or a contract research organization. Emphasis on business, experience with clinical processes and activities and associated ESP services, with excellent understanding of study management and overall integration of clinical data system and processes

Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills and Abilities: Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.

Job Title: Clinical Standard and Bio Stats Job Location: Pan India (Preferrable: Delhi or Mumbai) Exp Range: 10 - 18 Years Job Description: Roles and Responsibility: Contributes in building Product and solutions in Digital Data Flow, along with Product Team by providing Subject Matter expertise and knowledge on Industry Trends. Contributes to build differentiated Product offerings to maximize Sales and increase number of customers on Product. Co-leads the global strategic positioning & roadmap from a business view for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM (e.g. STDM, ADaM.) Co-leads the design & development for these solutions from a business view Co-leads thought leaderships and external visibility (e.g. articles, webinars, conferences, cross-industry meetings), initiates advisory boards Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships. Description: At least 7-18 years of global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA, gained preferably at top-15 pharma companies or clinical research organizations (CROs) Extensive hands-on experience with Digital Data Flow, data collection standards, biostatistical programming, STDM, ADaM, TFL and regulatory submission packages, including innovative tools and strategies for automation. Experience in applying AI in standardization, SDTM, ADaM and TFL generation. Experience in strategy setting for generating EDC build from study protocol, SDR Model, USDM Experience in innovative ways to automate testing and validation Track record of building respect and trust with customers, employees and other internal and external stakeholders and partners. Broad cross-pharma senior management network & preferably cross-industry forum expertise (e.g. CDISC, Transcelerate, IMI) Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language Strong interpersonal skills including negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity. Masters degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage

Key Responsibilities 1. Clinical Oversight Ensure adherence to treatment protocols and SOPs across all units. Monitor clinical indicators, patient outcomes, and audit reports. Guide units on medico-legal processes, compliance, and NABH standards. Review critical incident reports and follow up on action taken. Provide clinical direction during health emergencies or outbreaks. 2. Administrative Coordination Supervise hospital operations remotely through MIS, dashboards, and unit-level coordination. Support policy implementation and resolve escalated clinical-operational issues. Standardize workflows across departments in consultation with Unit Heads. Facilitate inter-unit coordination to maintain continuity of care. Monitor implementation of hospital-wide initiatives and strategic plans. 3. Consultant Recruitment & Review Lead the recruitment and credentialing of Consultant Doctors across Secure units. Periodically review consultant performance and clinical alignment with hospital standards. Coordinate with HR and unit heads for manpower planning and onboarding. Ensure compliance with credentialing, licensing, and renewal protocols. Advise on distribution of specialties based on patient demand and hospital goals. 4. Resource & Budget Oversight Review department budgets, resource utilization, and staffing data. Advise on cost-effective service delivery and equipment use. Support finance teams with clinical input on billing justifications and service coding. Recommend clinical resource optimization across multiple units. Track utilization trends and suggest corrective actions as required. 5. Compliance & Stakeholder Liaison Ensure legal, ethical, and clinical compliance through remote monitoring. Coordinate with regulatory bodies and represent hospital in external audits or legal matters as needed. Oversee medico-legal documentation and court-related submissions. Maintain liaison with empanelment bodies, insurers, and public health officials. Review compliance reports and initiate policy-level improvements when needed. 6. Strategic & Clinical Advisory Support new clinical programs, specialty launches, and service upgrades. Analyze patient feedback and recommend service improvements. Guide digital health initiatives and clinical innovation efforts across units. Identify emerging healthcare trends for long-term planning. Collaborate with leadership on enhancing Secure Hospitals clinical reputation. Strong Experience in Hospital Leadership or Medical administration. Note : Prospective candidate should be open for travelling to all the Units as part of the job as and when it is necessary. Min 7 to 10 days of Travelling in the 1st 6 months. After 6 months one can plan the Travelling Schedule according to the Requirement. Qualifications MBBS Hospital Admin qualification preferred 10+ years in hospital leadership or medical administration Strong remote coordination, compliance, and strategic planning skills Key Skills and Competencies: Strong leadership and decision-making abilities. Excellent communication and interpersonal skills In-depth knowledge of hospital management systems and clinical protocols. Ability to handle crises and manage conflicts. Familiarity with healthcare regulations and accreditation standards.

What you will be doing: Own the sales cycle end-to-end, selling to C-suite executives at midsize and large companies Work with the executive team at Loop to shape the roadmap for diagnostics and health care products Accurately forecast and maintain a desirable sales pipeline to achieve quarterly targets Use your experience in need identification research to formalize a GTM strategy Developing sales strategies to relentlessly achieve and exceed monthly and quarterly sales targets Creating world-class healthcare solutions that connect Loop s ecosystem with customer s requirements Work with clinical operations to manage delivery of annual health checkups to customer s satisfaction What we are looking for: At least 4 years of experience as a quota-carrying sales representative in the B2B space - preferably in healthcare Genuine customer empathy and strong time management skills Familiarity with G Suite and Microsoft Office, including Excel Deep understanding of the healthcare industry Fluency in English, Hindi /or other relevant regional languages Hustle - were a growing company that moves and reacts fast

Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Role : Clinic Manager Location : Secunderabad Results expected on the job Convert leads to sales retain customers and manage doctor team Grow clinic revenue to 40 lakhs per month and profit margin of 30%. Convert 85% footfall to paying customers during the 1st visit to the clinic. Achieve repeat consultation of 60% Work description Work involves consultative selling of high-value treatment plans at clinic reception Ensure timely inventory backfill of medicines, upkeep of facilities Comply with SOP to achieve clinic operations excellence certification Manage doctor schedules, customer escalations, Track sales KPIs and execute root cause analysis and improvement plans Ensure brand hygiene, dress code, grooming, and service standards Comfortable with weekend work due to high customer flow on Sat, Sun Candidature requirements (must have) Proven track record in consultative selling high-value services/products treatment plans, memberships, programs Dont apply if you lack prior experience in face-to-face selling at clinic, centers, stores Has the knack to take ownership and independently manage clinic operations If interested drop your CV on - nikita.thetalentkeepers@gmail.com

Department- CMR (Clinical, Medical, Regulatory & Pharmacovigilance) Location- Bangalore / Hyderabad Are you an experienced medical professional and passionate about Clinical Medical? Does being part of a growing, yet dynamic environment excite you? If yes, then you may be the one we are looking for as Clinical Medical Manager for Novo Nordisk India. Apply now! The position As a Clinical Medical Manager, you will be responsible for : Facilitate the execution of clinical trials related to New Therapy Areas (including CVD, CKD, NASH) by providing medical/scientific expertise and advice. Identify and map KOLs, investigators, and research centres within the relevant therapy areas. Collect early scientific insights and guidance by discussing relevant early development data with external medical and scientific experts. Contribute to delivering successful clinical trials (phase I-IV) in collaboration with clinical operations. Provide timely medical guidance and internal training to clinical staff. Engage in extensive scientific communication both internally and externally, requiring strong presentation skills. Performing ad hoc visits, Supporting attendance at investigator meetings, ensuring KOL inclusion in clinical trials and engaging key investigators to communicate trial results. Qualifications To be successful in this role, you should have the following qualifications: MD in any discipline with a strong clinical research/medical affairs background. 5 years of clinical or pharmaceutical industry experience with strong experience in human healthcare research either from university, CROs, or pharmaceutical industry. Expertise in therapeutic areas of relevance (CVD, CKD, NASH), preferably with authorship in peer-reviewed journals. Understanding of pharmaceutical drug development. Open to domestic and international travel in connection with site visits, congresses, and company events. Experience as a clinical trial investigator or sub-investigator. Understanding the specificities and nuances of the local healthcare infrastructure. About the department The CMR (Clinical, Medical, Regulatory & Pharmacovigilance) team based in Bangalore. Our team is dedicated to driving clinical trials and providing medical/scientific expertise in New Therapy Areas. We work closely with KOLs, independent professional associations, and patient advocacy associations to ensure the successful execution of clinical trials. The atmosphere is collaborative and dynamic, with a strong focus on scientific excellence and patient outcomes.

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Exp in PH II, III and IV studies Independently managing studies Manage vendors Develop study management plans, track study timelines and budget Interdepartmental coordination Required Candidate profile experience of managing clinical trials, preferably for multinational / global projects,

Oversee, lead & manage cross-functional team & external service providers. Accountable for conduct of clinical trials & functioning of the Clinical Operations dept. Ensure all projects are reviewed periodically & completed as per agreed timelines. Required Candidate profile Regular interactions with internal teams and Sponsors

The Medical Advisor is a member of the medical team which develops and manages health and wellness programs for Cigna customers. Together with a team of nurses and physicians she/he will ensure attainment of quality, production, timeliness, cost containment goals, and excellent customer satisfaction for both internal and external customers. Ability to review, investigate, and respond to external and internal inquires/complaints. Provides guidance and acts as a mentor or coach for the nurses and other non-clinical staff. He/she works with a multicultural population and is constantly aware of the cultural differences among that population and the geographical regions. Major responsibilities and desired results: Part of a clinical team that provides evidence based medical management services to customers worldwide Give evidence-based advice on medical claims, taking into account compliance, internationally accepted protocols and local and/or regional customs and regulations. Support and monitor the case management, disease management and other clinical services and assure quality of performance against QA standards to promote optimal service delivery and ensure accurate statistical data and reports. Give advice on appropriate corrective action if necessary. Assist in fraud detection. Assist is the coordination of processes for improving quality of care and health outcomes for specifically delineated projects or populations. Excellent communication and facilitation skills are keys to success. Assist and support the team in cost containment, assist in projects and service delivery to meet goals. Work together with the team on quality improvement and clinical management projects within Clinical Operations Serves as a resource/educator regarding specific areas of expertise. Able to create and implement appropriate educational clinical programs content for internal and external audiences and link with Cigna University resources. Other duties as assigned. Location: India Languages: English, fluent and any additional language will be considered. Experience: Medical Degree 3+ years of experience in insurance sector would be an asset.

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Required Skills: Experience understanding and interpreting data/information and its practical application Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through Ability to follow controlled processes Excellent spoken and written English Project management skills, including ability to prioritize work in order to meet required deadlines Problem solving ability Basic Qualifications: Degree with 2-5 years of experience working with regulatory documents in a biotech/ pharmaceutical environment Familiarity with clinical research and clinical regulatory documents Knowledge of clinical trial disclosure regulations, guidelines, and best practices ? EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Analyst Qualifications: BE,MCA,BTech Years of Experience: 3 - 5 Years Language - Ability: English - Advanced 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 world's 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 Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS Clinical SQL Databases Strong analytical skills Collaboration and interpersonal skills Written and verbal communication Ability to meet deadlines Adaptable and flexible Clinical Database Programming Experience in any clinical report development using PL/SQL or SAS JReview experience is added advantage. Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualifications BE,MCA,BTech

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA Years of Experience: 7 to 11 years 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 world's 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 Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for? SAS Clinical Oracle Procedural Language Extensions to SQL (PLSQL) Python (Programming Language) R Programming Clinical Database Programming Adaptable and flexible Ability to perform under pressure Problem-solving skills Agility for quick learning Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualifications BE,BTech,MCA