20 Clinical Monitoring Jobs

Role Responsibilities: Deliver full-spectrum nursing care in clinical settings. Support physicians during medical procedures and surgeries. Monitor vital signs and patient responses to treatments. Maintain precise and up-to-date patient records. Job Requirements: Graduate or postgraduate in nursing. Experience in hospital or surgical environments. Strong clinical and observational skills. Ability to work collaboratively in a multidisciplinary team.

The Medical Expert in TCO (Translational Clinical Oncology) serves as the medical leader for assigned global, roll-over, and long-term follow-up studies, as well as studies in the close-out phase. Additionally, they may provide medical co-leadership for assigned aspects of global, active TCO studies under the guidance of a Clinical Program Leader (CPL). TCO, a department under the Biomedical Research division, is responsible for designing and conducting early-phase clinical studies in cancer patients, acting as a connection between drug discovery and late-phase clinical development to deliver innovative medicines for oncology conditions. Responsibilities include providing medical support to the CPL, contributing to clinical sections of protocols, Informed Consents, publications, regulatory documents, and reviewing clinical trial data. The Medical Expert may also oversee program safety reporting, represent the CPL at project team meetings and Investigator teleconferences, and lead the review of TCO submission documents. Furthermore, they are responsible for managing close-out, roll-over, and long-term follow-up studies, ensuring the quality of clinical study reports, and engaging with stakeholders internally and externally. The Medical Expert mentors junior team members, maintains expertise in regulations and procedures, and advocates for continuous improvement of quality. Key performance indicators include managing studies within timelines and regulatory standards, demonstrating strong scientific writing skills, providing quality medical review of trial data, contributing to department objectives, and receiving positive feedback from stakeholders. The role requires adherence to Novartis Values and Behaviors. Minimum Requirements: - MD or equivalent medical degree with clinical training and certification - At least 5 years of pharmaceutical industry experience - At least 2 years of clinical practice experience - Experience in hematology/oncology preferred - Knowledge of GCP and oncology clinical trials - Strong project management, communication, and interpersonal skills - Ability to work independently and in a team, adapt to changing environments, and network effectively Skills: - Clinical Monitoring - Clinical Research - Clinical Trial Protocol - Decision Making Skills - Drug Development - Health Sciences - Life sciences - Medical Strategy - Regulatory Compliance Language: - English Novartis offers a collaborative environment where passionate individuals can work together to achieve breakthroughs that positively impact patients" lives. For those interested in joining the Novartis Network, opportunities can be explored through the talent community to stay connected with suitable career options. Additionally, Novartis provides benefits and rewards to support personal and professional growth. Novartis is dedicated to fostering an inclusive work environment that represents the diversity of the patients and communities served. Accommodations for individuals with disabilities are available upon request to ensure equal opportunities during the recruitment process or job performance.,

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: R&D Operations Job Sub Function: Clinical Trial Support Job Category: Professional All Job Posting Locations: Mumbai, India, PENJERLA, Telangana, India Job Description: A Senior, Site Manager is a mid-level site management role with typically 3-5 years of clinical monitoring experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. A Senior, Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Senior, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. A Senior, Site Manager may contribute to process improvement, training and mentoring of other Site Managers. A Senior, Site Manager is generally expected to be able to operate independently with little or limited supervision. Assists throughout the start-up, execution, and completion of clinical research studies, ensuring the safety and confidentiality of all study subjects. Documents site visits, investigational product assessments, and other relevant observations and identifies opportunities to improve outcomes. Acts as a point of contact for the clinical trial team and escalates issues to appropriate trial leaders. Gathers data on the clinical trial environment and measures against key performance indicators. Observes and trains patients on trial purpose and outcomes in accordance within all regulatory requirements, under general supervision. Maintains records and documentation of safety related events. Coaches more junior colleagues in techniques, processes, and responsibilities. Understands and applies Johnson & Johnson s Credo and Leadership Imperatives in day-to-day interactions with team.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: Mumbai, India Job Description: A Senior, Local Trial Manager is a mid-level trial management role with typically at least 2 years of clinical trial management or atleast 6-8 years of clinical monitoring experience. This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The Senior, Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The Senior, Local Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Senior, Local Trial Manager actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and Associate, Local Trial Managers. The Senior, Local Trial Manager may have some site management responsibilities. Configures systems to facilitate the operations of clinical trial phases to ensure staff are able to complete testing and analysis in a timely and effective manner. Analyzes standard operating procedures for clinical trial project management to ensure current methods are optimized and determine methods of improvement. Documents findings and events throughout the duration of a clinical trial project to present findings to leadership and ascertain organizational trends. Incorporates relevant modern advances in the field into clinical research to ensure the company stays up-to-date on the current knowledge and practices of the field. Edits and writes draft presentations and manuscripts for clients and stakeholders. Communicates with stakeholders and site staff on relevant discoveries or issues to ensure all involved parties are informed of project affairs. Coaches more junior colleagues in techniques, processes and responsibilities. Understands and applies Johnson & Johnson s Credo and Leadership Imperatives in day-to-day interactions with team.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: IN004 Bangalore, IN022 Hyderabad, Mumbai, India Job Description: A Lead, Local Trial Manager is considered as a senior trial management role with at least 4 years of clinical trial management experience or more than 6 years of clinical monitoring experience. This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The Lead, Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The Lead, Local Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Lead, Local Trial Manager actively leads or contributes to process improvement; training and mentoring of other LTMs and Site Managers (SM). Compared to Associate, Local Trial Manager and Senior, Local Trial Manager roles, a Lead, Local Trial Manager is often assigned to more complex protocols and can work across Phase 1 - 3 studies in multiple therapeutic areas as needed to drive business needs.Helps establish standard operating procedures for clinical trial project management, and constructs templates for use during clinical trials. Constructs systems to facilitate the process of clinical trial phases to ensure staff are able to complete testing and analysis in a timely and effective manner. Directs individuals during regulatory inspections to ensure staff is aware of standard procedures and expectations. Assesses and maintains in-depth knowledge of the departments study protocol and related procedures to stay up-to-date on the companys operations and have the ability to compare to industry standards and trends. Implements operational compliance with relevant regulatory and quality standards in accordance with federal and international requirements. Conducts on-site visits with clients, stakeholders, and other entities and records contact reports to inform others of the clinical trial project teams operations and archive comments from external parties. Coaches more junior colleagues in techniques, processes and responsibilities. Understands and applies Johnson & Johnson s Credo and Leadership Imperatives in day-to-day interactions with team.

Designation: Duty Medical Officer Location: Ranchi Qualification: MBBS; ACLS and VLS certification Experience: 0-1 years Other Requirements: • Proven expertise in new patient assessments, dialysis session monitoring, and emergency consultations. • Experience in ordering investigations and ensuring accurate medication administration. • Proficient in entering details into online portals, strong analytical skills, and effective English communication. • MS Office basic is essential. Interested candidates can send their resume to: Contact Number: 6291037010 / harpreet.gill@nephroplus.com

Hi , We have Opening for Clinical research Coordinator Location : Guwahati Salary : 23k take-home interested candidate Kindly drop your updated resume to below mail id Nithya_kumar@persolkelly.com Regards, Nithya CONFIDENTIAL NOTE: By submitting your resume or personal data, you acknowledge reading and agreeing to our Privacy Policy. You hereby provide voluntary consent to the collection, use, processing, and disclosure of your data by us and our affiliates, in line with the Privacy Policy. and applicable laws. If you wish to withdraw your consent or have any concerns, you may submit a request to our designated consent manager, as outlined in our Privacy Policy. We prioritize your privacy. SECURITY NOTE: We at PERSOLKELLY India or our representatives, do not ask job seekers for fees, personal banking information, or payments through unofficial channels. Official communications will only come from @persolkelly.com. Report any suspicious activity to Contactus_in@persolkelly.com. Click here to find out how you can safeguard yourself from job scams

Review Site Visit Reports (SVRs) to ensure they meet or exceed quality standards and support goals of quality, subject safety, data integrity and regulatory compliance. Use tools and techniques to ensure the efficient and effective review of Site Visit Reports and their associated attachments, in compliance with IQVIA SOP, ICH/ GCP guidelines, and protocol requirements Essential Functions Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA/applicable SOPs, and GCP guidelines. Review SVRs to ensure findings requiring corrective and /or preventative action plans are documented and followed up to resolution, to ensure high quality reports. Participate on the project team for all SVR review activities and identifies and escalate CRA and /or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery. Provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study and partner with the project team members to decrease the level of corrections/additions needed on reports by providing insight and training of the SVR annotations. Identify and track the project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers. Participate in meetings with project team to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs. Assist with identification of the trends emerging from the Issue Escalation Log. Provide coaching to CRAs to decrease the level of corrections/additions needed on reports. Provide quality improvement support such as quality checks, data trending, providing back up support and mentoring and coaching of junior staff members. May take on special project assignments related to function/corporate initiatives. Qualifications Bachelors Degree Healthcare or other scientific discipline or educational equivalent Req 7-8 years of Clinical Research experience, including a minimum of 3 to 4 years on-site monitoring experience Req Or Equivalent combination of education, training and experience. Req Strong knowledge of and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Through knowledge and understanding of the Clinical monitoring processes and sound knowledge of clinical trial systems and applications Demonstrated skill in understanding and executing complex study designs as well as multiple studies Strong written and verbal communication skills. Effective time management and organizational skills, and the ability to manage competing priorities Ability to work independently with good analytical and problem solving skills Demonstrated ability to work across cultures and geographies with a high awareness and understanding of cultural differences High quality orientation, with a focus on attention to detail Ability to establish and maintain effective working relationships with coworkers, managers and clients. Fluent in English, both spoken and written.

Role & responsibilities Identifying/selecting an investigator who will be Responsible for The conduct of The trial at The trial site. Liaise with doctors/consultants or investigators on conducting the trial. Setting up The trial sites, which includes ensuring each centre has The trial materials, including The trial drug often known as The investigational medicinal product. Training The study staff in standard operating procedure for The clinical trials as per applicable regulatory requirements. Verify that investigator and investigators team are adequately trained and comply with The protocol. Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements. Monitoring The trial throughout specified duration involving Monitoring visit to The trial sites. Source data verification Informed consent form review, case report form review, investigational drug accountability, and adverse event review. Ensuring all unused trial supplies are accounted for. Writing visit reports, filing and collecting trial documentation and reports. Preferred candidate profile Pre-requisites for - Sr. Project Executive / CRA / Sr. CRA: B. Pharm/ BSc / Biotech + Clinical Research Degree / Diploma / Masters Candidate must possess excellent communication skills and ability to build excellent relationships with the trial staff and colleagues. ICH-GCP knowledge is a must. Ready to travel within and out of Mumbai at various trial sites. Willing to travel 50-60%. Attention to detail Good organisational and administrative skills (knowledge of word and Excel) Perks and benefits Salient Features of this job Chance to work in a supportive and flexible environment. Directly interact with customers from the USA and Europe. Vedic Lifesciences has been rated highly by our alumni last 22 years, as a great place to work and learn

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical training material (i.e. therapeutic area and study protocol training material) Delivers internal and external study protocol and therapeutic area training courses Provides medical expertise and consultation within the Company on key therapeutic areas of the clinical development program Provides guidance to all involved departments on the medical and scientific aspects of the assigned clinical trials/projects. Responds to medical queries from all involved parties in assigned clinical trials (e.g., CRAs, Project Managers, Clinical Operations Managers, Investigators) and collaborates with all concerned staff in maintaining an up-to-date study-specific Q&A log Is available 24/7 to respond to urgent medical/protocol related issues derived from an Investigational Site, as applicable Performs periodic medical review of the data from clinical trials according to the study-specific Medical Review Plan requirements (e.g., review of eligibility, review of efficacy and safety data). Performs real-time medical review on urgent medical and safety issues, as needed Collaborates with and provides medical input to the Data Management staff to ensure the successful development of the study-specific eCRF Attends Investigator Meetings and Conferences, as applicable Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection and ICH GCP requirements Preferred candidate profile Required Medical Degree (MBBS, MD) Preferred: Clinical experience in the therapeutic area of the assigned study or of the Companys clinical development program - Preferred: 2 years of experience in a CRO or in the pharma industry in a relevant role (Clinical, Medical Information, Medical Affairs or PV) Key competencies Exceptional written and oral use of English In-depth knowledge of medical and drug terminology Good medical judgement and ability to make medical decisions Excellent communication skills Excellent business acumen Initiative taking and team working attitude Excellent Organizational skills Innovative thinking Excellent IT skills Deep understanding of the Clinical Development industry

Role & responsibilities Job Requirements: Proven expertise in commercial interior fit-out projects ranging from 10,000 to 200,000 sq. ft. , managed independently from site kick-off to final handover . Educational qualification: B.E./B.Tech in Civil/Interior Design/NICMAR or equivalent . 1520 years of relevant experience in office interior fit-out project execution. Strong technical knowledge of services coordination , including: Electrical systems Fire safety/security Networking HVAC Excellent client handling , site coordination , and team leadership skills. Ability to represent management and reduce operational dependency on directors by 80% . Key Responsibilities: Client and Stakeholder Engagement: Lead end-to-end client interactions to ensure project satisfaction. Conduct regular reviews with designers, clients, architects, consultants, and contractors . Act as the primary client representative for all site-related matters. Project Planning & Execution: Manage multiple projects simultaneously through coordination with Site PMs/Engineers. Track and update project schedules using Microsoft Project (MPP) . Ensure project milestones and deliverables are met on time and within budget. Cost and Vendor Management: Support the purchase team in vendor identification, evaluation, and finalization . Ensure cost optimization in both rate and quantities. Monitor vendor performance through defined KPIs and evaluation parameters. Documentation & Compliance: Maintain accurate and timely documentation for both internal and client reporting. Ensure Minutes of Meeting (MoM) are recorded and shared after every key discussion. Coordinate and get approvals on change requests from clients. Operations Leadership: Head backend operations and align with the organization’s business goals. Resolve site-level escalations and ensure timely decision-making. Liaise with statutory authorities, inspectors, and labor unions (e.g., Mathadi) for compliance. Reporting & Performance Monitoring: Generate and maintain detailed monthly MIS reports for all ongoing construction activities. Present project updates during weekly Key Priority Meetings (KPM) . Ensure weekly reports and Monthly Management Reports (MMR) are shared with management. Project Handover & Quality Assurance: Implement and complete the handover checklist within 15 days post-project completion. Ensure snaglist closure within one month of handover. Maintain quality standards and secure client approvals for any specification deviations. Team Management: Ensure timely recruitment and onboarding of project team members. Lead regular training programs for project teams. Conduct quarterly performance reviews and submit evaluations to HR. Handle internal team issues and ensure backup coverage and resource alignment. Billing & Payments: Ensure timely submission of bills and payment clearances to maintain project pace. Post-Handover Support: Oversee Defect Liability Period (DLP) and manage post-handover support through internal teams and vendors. Process Improvement & Implementation: Ensure adherence to DSIPL project processes and intranet protocols . Recommend and implement process improvements for project excellence. Ensure site safety compliance in coordination with the safety team. Business Development: Support business development efforts through client satisfaction, referrals, and industry networking. Preferred candidate profile

• Respond to queries/ clarifications from EC/ IRBs and on sites • Attend drug safety/external meetings/investigator meetings • Patient eligibility review • Review AE/ SAEs • Protocol training of site staff, CRAs etc

Premier Research is looking for a Clinical Trial Associate II to join our Global Clinical Monitoring and Site Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. Document Management Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) in collaboration with the clinical team as defined by the organizations or Sponsor s SOPs and all applicable regulatory requirements. Creates and maintain placeholders in the TMF based on TMF filing plans, expired documents, study milestones, site staff changes, and other applicable events. Reviews site documents and verifies they meet or exceed all company, sponsor, regulatory authority, and ALCOAC standards. Performs Quality Review and completeness checks of relevant eTMF sections in compliance with company or Sponsor processes throughout start up, maintenance, and close out activities and ensures follow up with clinical team of resolution of findings. Conducts follow up with the internal team on TMF queries to ensure timely resolution. Routinely runs and distributes eTMF reports to clinical team to facilitate quality and compliance. May assist SSUAs/CRAs with essential document collection and review during startup, maintenance and close out. May support the translation of site documents or reviews translations of site documents, if required. Data entry, Tracking, Reporting and System Support Assists the clinical team with CTMS set up and data entry into project tracking systems, as applicable, including but not limited to site contact updates, site address updates, maintain site assignments and site activation activities, e.g. vendor activities. Assists the clinical study team in the tracking and documentation of Investigators Brochure and safety report distribution as well as other documents/materials sent to sites, e.g. newsletters. Assists with managing and tracking access to systems, (i.e. CTMS, Vendors, EDC, IWRS, etc.) for site staff and clinical team; including conduct of routine reviews, to ensure access removal. Reviews the project specific training matrices and reports to ensure compliance of clinical team. May create CRA workflows to manage site follow up items. Other Attends internal clinical meetings as required and assist with meeting preparation and follow up (decisions, actions, issue logs). Supports the CRA/clinical team in liaising with third party vendors to solve and follow-up on issues e.g. on study equipment, translations. Supports other study specific tracking, such as Q&A log. Participates in available internal training offered to increase therapeutic knowledge. Assists the clinical team with the development of study material, such as create Investigator/Pharmacy site files in collaboration with the study team before Site Initiation Visit; includes working with vendor for creation and distribution of ISF Binders (upload documents, review proofs, trigger shipments). Coordinates general office logistical activities as requested May mentor and train less experienced CTAs May be a point of contact for IT issue resolutions Identifies, manages, escalates issues where appropriate and collaborates with Project Team and Line Manager to identify solutions. May participate in departmental initiatives. Performs additional duties and assignments as required.

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

At Allucent , we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Clinical Research Associate Contractor (Sr.CRA) to join our A-team (remote). As a Sr. CRA at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. In this role your key tasks will include: Governs highest possible quality standards for trial monitoring activities. Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours. Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines: Performs efficient site management in line with study budget. Prepares and submits quality Site Visits Reports and Contact reports. Maintains and updates CTMS in compliance with SOPs and study-specific directives. Acts as Document Owner for collected documents. Conducts co-monitoring as needed. Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF). Liaises with project team members and Sponsor to track study progress and milestones. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines. May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR). May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training. May perform assessment visits. Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel. Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution. Acts as the lead contact in case several CRAs involved for a same study in same country. Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed. May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable. May participate in meetings with clients. May support project manager/CTL and project functional leads in the project oversight and management. Supports site staff in preparation for study related site audits and inspections. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. To be successful you will possess: At least five years clinical monitoring experience and/or relevant clinical trial experience. Relevant life science degree / medical / nursing background, or combina

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.

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.

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.

>To connect top practitioner doctors of different specialist all over India >To structure a proper process to establish & conduct medical survey for research & strategy purpose > Establish a proper compliance & register for conducting clinical trials

The Medical Monitor will serve as the primary medical expert responsible for the safety and scientific integrity of clinical trials. This role provides medical oversight to ensure patient safety, proper conduct of trials