The Lead - Clinical Research will oversee and manage the execution of clinical studies to ensure compliance with study protocols, sponsor SOPs, Good Clinical Practice (GCP), and all applicable regulatory guidelines. The role involves providing operational leadership for end- to- end clinical trial activities - from site identification and feasibility to study closeout - while ensuring data quality, subject safety, and timely project delivery.

Key Responsibilities :

- Lead assigned clinical studies, ensuring full adherence to protocols, GCP, SOPs, and regulatory requirements.

- Perform, review, or oversee the following monitoring activities directly or through SMOs/CROs:

- Site Identification and Feasibility Studies

- Site Selection, Initiation, Monitoring, and Closeout Visits

- Ensure timely submission of visit reports and follow- up letters to sites, and communicate updates to the Clinical Project Manager.

- Conduct and/or facilitate training of study teams and clinical sites on study protocols, GCP, and relevant local regulatory requirements.

- Maintain close collaboration with sites for patient recruitment, follow- up, and protocol compliance.

- Ensure timely Ethics Committee submissions and reporting of adverse events (AEs/SAEs) to the sponsor and IRB/IEC.

- Oversee drug accountability, including supply/resupply and reconciliation of study materials at sites and sponsor location.

- Ensure timely CRF retrieval and accurate data flow as per study timelines.

- Support the Clinical Project Manager in study oversight, progress tracking, and risk management to ensure timely project completion.

- Maintain and regularly update clinical study trackers, including finance and project status updates.

- Serve as the primary point of contact for internal stakeholders - including Clinical Project Manager, Product Management, Data Science, Formulation & Development, and other functions.

- Ensure Central Site Files and Project Management Files are accurate, updated, and periodically reviewed as per SOPs.

- Coordinate the archival of study documentation (both electronic and physical) post- study completion.

Role Requirements:

- Education: Graduate or Postgraduate degree in Science, Pharmacy, or related disciplines (B.Sc, BDS, B.Pharm, M.Pharm, M.Sc).

- Experience: Minimum 4-5 years of experience in clinical study monitoring at a sponsor or CRO organization.

- Proven experience in site monitoring and clinical trial coordination, with a sound understanding of end- to- end study processes.

- In- depth knowledge of ICH- GCP, Schedule Y, and applicable clinical research regulations.

- Proficient in MS Office tools and fluent in written and spoken English.

- Willingness to travel approximately 25- 50% based on project requirements.

Key Competencies:

- Strong understanding of clinical research operations and regulatory frameworks.

- Excellent organizational, documentation, and communication skills.

- Ability to coordinate across cross- functional teams and external partners.

- High attention to detail, quality, and compliance.

- Proactive problem- solving and time management abilities.