Clinical Research Network India Pvt. Ltd.

Role & responsibilities : Provide medical oversight and support for clinical trials, including the review of study protocols and medical documents. Act as a subject matter expert for clinical trial design, execution, and interpretation of clinical data. Evaluate and manage adverse event reporting, ensuring compliance with regulatory requirements. Conduct medical assessments and offer guidance on patient safety, recruitment strategies, and eligibility criteria. Collaborate with clinical operations, regulatory affairs, and data management teams to ensure smooth trial progression. Develop protocol, informed consent documents, Diary Card, Source Documents, Case Report form, Study Logs, Clinical Study Report, Investigator Brochure and other regulatory documents. Prepare and review clinical study reports, ensuring they are in line with project and regulatory standards. Liaise with external stakeholders, including clients, regulatory bodies, and ethics committees. Stay current with medical advancements, guidelines, and regulatory changes affecting clinical trials. Establishing and maintaining pharmacovigilance (PV) system. Responsible for the preparation and approval of PSMF, aggregate reports, Risk Management Plans (RMP), providing medical input to risk minimization measures, RMPs and aggregate reports.