- BABE and Phase Trials ICH-GCP and ethical aspects for conduct of a clinical trial study
- execution teams to work upon clinical studies across two different clinical study management
- Providing valuable medical inputs to the Medical Writing team comprising of protocol writers and report writers Organize and schedule activities from protocol writing, IEC submission and eCTD specification for study report submission

- Manage a volunteer registration and management unit with a volunteer registration data base comprising
- Establish firm execution systems and SOP's governing clinical execution aspects and completed studies with GCP compliance

- Reporting recording and management of several adverse events in accordance with safety principles and regulatory guidance




- Establish Adverse Event tracking system which aided in following volunteers who encountered adverse events

- Devise strategies across sample processing area and ensure minimal logistics utilization for cold chain maintenance for samples
- Establish eCRF documentation for source data management

- Preparation of Patient Information Leaflets
- Scrutinizing healthy volunteers for BA/BE study in coordination with Principal Investigator
- Supervise day to day activity assigned to study personnel

- Ensuring the proper functioning of Emergency care equipment s before study commencement and throughout study period
- Supervise day to day activity assigned to study personnel

📌 Physician (Thane)
🏢 Bio Scientific Research Laboratories (BIOSRL)
📍 Thane