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Sr. Executive
Job Location:
Monthly Salary:
Posted:
2 October 2026 (5 days ago)
Posted:
Application Deadline:
30 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
- Responsible for developing establishing and maintaining QA procedures related to clinical trials to ensure compliance to applicable regulatory guidelines.
- Review of Clinical Trial related documents like Investigators Brochure Clinical Trial Protocol Informed Consent Document associated plans and manuals.
- Ensuring the conduct of clinical trials as per applicable guidelines SOPs and protocols
- Plan conduct and/or lead clinical trial site audits CRO/vendor audits central laboratory and other critical service provider audits facility audits and TMF/clinical documentation audits.
- Prepare audit reports and communicate observations clearly based on risk and regulatory impact.
- Track and evaluate audit responses and CAPA commitments for adequacy and effectiveness to ensure timely closure of audit findings.
- Responsible for the external audits/inspections and its CAPA resolutions and implementation.
- Strong knowledge of ICH-GCP NDCT (2019) and applicable regulations.
Required Experience:
Exec
About Company
We develop novel oncology therapeutics for unmet global medical needs with fully-integrated drug discovery and development capabilities.
