1. Planning, conducting, supervising and reporting of BA/BE studies in accordance with Protocol, ICH-GCP guideline and regulatory requirements. 2. Coordination with external service providers and cross-functional teams 3. Data submission of clinical studies as per requirement to Pharmacovigilance and RA department. 4. Regulatory inspection compliance 5. SOP preparation, review, revalidation, and training to all team members. 6. Plan Calender training. External training such as ACLS BLS, GCP. Mock drills , internal trainings and seminars.
