Job Description

Department Details
Role Summary
Job Requirement for Clinical Research Role - Assistant Manager
- Oversee the clinical Operations and study conduct at CROs
- Qualification of CROs or Vendors or sites or Monitors
- Preparations of Protocol Synopsis and Review the Protocol, ICF, CRF, other study documents
- Conduct Remote/On site Monitoring of Clinical & Bioanalytical phases
Key Responsibilities
- Oversee the clinical Operations and study conduct at CROs
- Qualification of CROs or Vendors or sites or Monitors
- Preparations of Protocol Synopsis and Review the Protocol, ICF, CRF, other study documents
- Conduct Remote/On site Monitoring of Clinical & Bioanalytical phases
- Review the CSR
- Handling regulatory Queries and submission of regulatory query responses to RS team
- Evaluation/assessment of study feasibility, budget preparation.
- Evaluation of In-licensing dossiers
- Preparation and Review of Controlled Correspondence scientific advice for Regulatory-submission
- Clinical Overview preparation & Review
- Supporting Regulatory team in submission of ANDAs to extended markets.
Educational Qualifications
Required Education Qualification: M.Pharma
Required Experience: 5 - 10 years

Skills Required