SESeven Consultancy
Clinical Trials
Chennai ₹5-8 LPA Posted 12 Dec 2025
FULL TIME
Clinical Trials
Medical Writing
Clinical Data Management
Pharmaceutical
Medicine
+1 more
Job Description
- Creating and writing trial protocols and presenting them to the steering committee.
- Identifying, evaluating, and establishing trial sites, and closing sites after trial completion.
- Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
- Liaising with ethics committees regarding the rights, safety, and well-being of trial subjects.
- Ordering, tracking, and managing investigational products (IP) and trial materials.
- Overseeing and documenting IP dispensing, inventory, and reconciliation.
- Protecting subject confidentiality, updating their information, and verifying IP administration according to protocol.
- Conducting regular site visits, coordinating project meetings, and preparing visit reports.
- Implementing corrective action plans for underperforming sites.
- Liaising with regulatory authorities as required.
- Ensuring compliance with SOPs, local regulations, ICH, and GCP guidelines.
- Performing other clinical research tasks and responsibilities as assigned.