Sun Pharma Biological Sciences Trial Assistant Job Opening – Apply Online
Title: Senior Regional Trial Assistant (G11B)
Date: Jun 27, 2024
Location: Gurgaon – R&D
Company: Sun Pharmaceutical Industries Ltd
Job Summary
RTA performs administrative and supportive activities from study start-up to execution and close out as assigned by Regional trial lead and Trial Operations Manager to ensure quality and timeliness across study deliverables to time, quality and cost objectives.
RTA is expected to adhere to required procedures and quality in compliance with Sun Procedural Documents, ICH-GCP and local regulations.
Area Of Responsibility
- Set-up, maintain and/or close out study related files and documentation (e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries).
- Perform Regulatory submissions (Ethics Committee and Health Authority), interim updates and health authority portal updates as needed per regulatory requirements.
- Ensure essential documents for assigned study/ies, study and site related documentations are uploaded to eTMF in timely manner to keep TMF Inspection ready all the time.
- Maintain timely and effective communication with internal project team members.
- Support RTL in maintaining study trackers and reports (e.g. recruitment, payment, regulatory trackers, safety reporting, monitoring related, quality oversight etc.).
- Coordinate with vendors for activities like translations, printing, supplies, lab etc.
- Coordinate on maintaining site related supplies and mgmt.
- Support study related meeting coordination’s and follow-up on actions.
Geographic Scope/Market: India Cluster
Budget (if applicable): Regional Clinical Operations Unit Budget
Work Conditions: Full time
Physical Requirements: Presence at work
Travel Estimate: Frequent
Education and Job Qualification: Minimum graduation in biological sciences and allied domains. Added qualifications will be preferred.
Experience: Should have at least 2-3 years of experience in a similar capacity with experience in clinical trial coordination or administration.
APPLY ONLINE HERE
