Role & responsibilities 1. Responsible for clinical trial medical science related activities like preparation of protocol, Informed consent form, CRF, other study related documents and SOPs in line with ICH GCP, Indian and global regulatory. 2. Conduct relevant literature search for required for protocol and manuscript writing. 3. Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines. 4. Ensure to follow all clinical and regulatory guidelines, processes and systems for medical science activities and ensure compliance to internal medical writing SOPs for Clinical trial. 5. Compiles, writes and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. 6. To follow the designed process to write, review protocol for trials and work closely with operation team to ensure high quality operationally feasible protocol for clinical trial. 7. Prepare and review SOPs specific for medical writing for clinical trial. 8. Work closely with different stakeholders for review of study documents (such as statistical analysis plan etc) and data review activities. 9. Any other responsibilities as assigned by the HOD/Management Preferred candidate profile Candidate must have exposure in Late Phase / Clinical Trial protocol writting. Experienced in Medical Writing with expertise in overseeing early and late phase clinical studies. Responsible for working with cross-functional teams involved in protocol development. Ensures timely and high-quality development, review and finalization of study protocols, informed consent forms and other documents in alignment with ICH-GCP guidelines, applicable national and international guidelines sponsor/regulatory requirements. Ensuring collaboration with multiple stakeholders across Clinical Operations, Biostatistics, Bioanalytical, PK and other departments to maintain scientific accuracy, operational efficiency, and regulatory compliance. Additionally, involves managing communication with ethics committees and regulatory authorities (e.g., CDSCO), monitoring submission timelines, addressing queries and ensuring up-to-date knowledge of evolving global regulatory guidelines.
Role & responsibilities Develop and manage comprehensive project plans, including timelines, budgets, resource allocation, and risk mitigation strategies. Oversee all aspects of trial startup, including site selection, contract negotiation, IEC/IRB submissions, and study team training. Monitor trial progress against established milestones and timelines, proactively identifying and addressing potential delays or roadblocks. Manage project budgets, track expenses, and ensure cost-effectiveness. Collaborate with cross-functional teams (e.g., medical, biostatistics, data management, regulatory) to ensure seamless project execution. Manage vendor relationships, including selection, contract negotiation, and performance monitoring. Serve as the primary point of contact for study sites, sponsors, and other stakeholders. Facilitate effective communication among study team members, ensuring timely dissemination of information and updates. Prepare and present regular project status reports to management and stakeholders. Foster a collaborative and productive working environment within the study team. Ensure adherence to all applicable regulations, guidelines (e.g., GCP, FDA), and company SOPs. Monitor data quality and integrity, identifying and resolving any discrepancies or issues. Implement quality control measures and participate in audits and inspections. Maintain accurate and up-to-date study documentation. Identify and assess potential risks to trial success, including patient safety, data integrity, timelines, and budget. Develop and implement risk mitigation strategies to minimize the impact of potential risks. Proactively monitor and manage risks throughout the trial lifecycle. Provide leadership and guidance to study team members, fostering a positive and productive work environment. Delegate tasks effectively, ensuring appropriate distribution of responsibilities. Mentor and develop junior team members, promoting professional growth and development. Perform other duties as assigned by HOD. Preferred candidate profile Bachelor's degree in a scientific or related field; Master degree preferred. Thorough understanding of GCP, FDA regulations, and other relevant guidelines. Proven ability to manage complex clinical trials, including budget management and vendor oversight. Strong leadership, communication, and interpersonal skills. Excellent organizational and time-management skills. Proficiency in clinical trial management software and Microsoft Office Suite. Ability to work independently and as part of a team.
Job Summary The Medical Monitor will serve as the primary medical expert for late-phase (Phase IIIV) clinical trials, ensuring subject safety, scientific integrity, and regulatory compliance throughout the study. This role involves providing ongoing medical oversight, safety data review, protocol compliance assessment, and guidance to investigators and the clinical team. The Medical Monitor acts as the key medical contact for study teams, sites, sponsors, and regulatory authorities. Key Responsibilities Provide continuous medical and scientific oversight for late-phase clinical studies. Ensure subject safety through regular review of adverse events, SAEs, and safety signals. Conduct medical data review of patient profiles, laboratory results, and efficacy/safety endpoints. Support protocol development, amendments, and review of study documents (ICF, CRFs, SAPs, CSRs). Advise investigators on subject eligibility, protocol compliance, and management of study-related medical issues. Participate in medical monitoring calls, safety review meetings, and Data Safety Monitoring Boards (DSMBs), if applicable. Collaborate with project managers, CRAs, and sponsor teams to ensure study timelines and quality deliverables. Provide medical input for regulatory queries, clinical study reports, and publications. Train and mentor PI and clinical staff on protocol and therapeutic area. Perform onsite Medical Monitoring Visit as per MSA Education - MBBS/MD Pharmacology Experience Requirement - 1-2 Years Skills Strong clinical knowledge and ability to interpret safety and efficacy data. Excellent understanding of GCP, ICH guidelines, and regulatory requirements for late-phase trials. Analytical and detail-oriented with sound clinical judgment. Effective communicator with ability to interact with investigators, sponsors, and cross-functional teams. Proficiency in medical writing, safety data interpretation, and protocol compliance review. Ability to manage multiple trials simultaneously and work under strict timelines. Preferred Certifications Advanced training or certification in Clinical Research/Drug Development Pharmacovigilance or Safety Monitoring certification Therapeutic areaspecific training (e.g., oncology, cardiology, endocrinology) will be an added advantage
Role & responsibilities Preferred candidate profile q Act as a Study Physician/Co-investigator q Prepare and review protocols for clinical studies q Co-ordinate activities related to IEC q Communicate IEC related issues to all concerned q Ensure compliance to protocol, SOPs and Regulatory requirements q Monitor and co-ordinate for volunteer recruitment and screening procedures q Handle medical confidential reports and case management. q Coordinate with Project Coordinators for all project related matters q Monitor and manage adverse events q Coordinate with panel of consultants to seek medical opinion as and when required q Ensure timely response to QA findings q Interact with sponsors on medical related matters q Handle safety related issues and ensure appropriate communication q Prepare and review reports for clinical studies q Write and review related SOPs q Contribute towards scientific development of the organization q Help maintain and update all the systems and SOPs in the department q Train the staff on CPR, GCP and related guidelines and all departmental and relevant SOPs. Any other responsibilities as assigned by the HOD/Management