Department: Clinical Operations
Reports To: Site Head

Job Summary

The Clinical Head is responsible for the overall management and oversight of clinical operations, ensuring the ethical, scientific, and regulatory conduct of clinical trials. The role includes planning, execution, monitoring, and timely completion of Bioavailability/Bioequivalence (BA/BE) studies and Phase IIV clinical trials in compliance with ICH-GCP, NDCTR 2019, CDSCO guidelines, and applicable SOPs.

Key Responsibilities

- Lead and oversee all clinical operations for BA/BE and clinical trials.
- Ensure participant safety, protocol compliance, and data quality throughout the study.
- Supervise screening, dosing, sample collection, medical assessments, and study conduct.
- Ensure compliance with ICH-GCP, NDCTR 2019, CDSCO requirements, and institutional SOPs.
- Review and approve clinical documents, protocols,



source documents, and study reports.
- Coordinate with Sponsors, CROs, Ethics Committees, investigators, and regulatory authorities.
- Manage clinical staff, including physicians, nurses, coordinators, and paramedical personnel.
- Support sponsor audits, QA audits, and regulatory inspections, ensuring timely CAPA implementation.
- Monitor study timelines, resource utilization, and operational performance.
- Qualification & Experience

- MBBS (MD in Pharmacology, General Medicine, or a relevant specialty preferred).
- Minimum 7-10 years of clinical research experience, including 5 years in a leadership role within a CRO, BA/BE center, or clinical trial unit.

📌 Head Clinical (Kandla)
🏢 Rusan Pharma
📍 Kandla