- Monitoring of clinical and BA/BE studies.
- Review of clinical study reports and documents.
- Coordination with internal stakeholders like formulation, regulatory, purchase and finance teams.
- Coordinating with external vendors including CROs, packaging vendors, consultants etc.
- Well versed with ICH GCP and regulatory guidelines on BE and clinical studies.
- Well versed with clinical study site and CRO monitoring.
- Good verbal and written communication skills.
- Preferably worked at sponsor end in the past.
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Executive - Mumbai, India - Encube Ethicals Private Limited
Description
Job Description :-
Skill Requirements :-