Cipla Limited is looking for eligible candidates for the following posts of Clinical Trials team member at Mumbai Maharashtra.
Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, and depression; other medical conditions.
Title: Team Member – Clinical Trials
Department: Medical Services
Qualification: M. Pharm or B. Pharma with MSc. or diploma in clinical research
Experience: Minimum 5-7 years’ experience with at least 2 years of independent project coordination experience.
Location: Mumbai Central
Salary: Not Disclosed
As Assistant Manager for clinical projects assigned and responsible for clinical operations, project coordination, and vendor management
- Perform site visits and prepare reports in compliance with Cipla SOPs
- Vendor identification, review & management which includes but not limited to translation agency, insurance, CTSM, biological & material destruction agency, Printing agency, legal and CRO
- Coordinate regulatory submission which will include DCGI and EC
- To organize investigator’s meeting
- Overlooking registration of clinical trials on CTRI
- To maintain Trial Master File and oversight site master file (as applicable)
- Site personnel training on various guidelines as per industry standards of clinical trials
- Prepare weekly reports and update the reporting manager and activities completed and upcoming activities.
- Organize and participate in weekly meetings with CRO for study updates and share study status reports.
- To perform co-monitoring/sponsor oversight visits to ensure quality of data generated
- Timely review site visit reports in compliance with SOP
- Identify and send requests for proposals for outsourced activities to vendors. Share quotes with reporting manager received from the vendor. Negotiate and close clinical trial study proposals with vendors.
- Assist reporting manager in defining payment schedule to investigators and vendors.
Compliance and Governance
- Ensure compliance with the internal policies, procedures, and applicable regulations
- Provide Oversight to progress of outsourced trial to CRO and provide regular updates to reporting manager
- Collaborate with local regulatory team in the activity of application for clinical trial and support Head, Clinical trials/designee for presentation(s) to SEC/DCGI and/or other to regulatory bodies (as applicable)
- Support during regulatory inspection and provide timely response to the inspection observations (as applicable)
- Development, Revision, and Review of SOPs of clinical trial group (as applicable)