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.