
Clinical Compliance Specialist
1 week ago
Job Overview
We are seeking a highly experienced and skilled Clinical Quality Assurance Compliance professional to join our team.
This role will be responsible for oversight of end-to-end clinical trial activities from a quality perspective. The successful candidate will be accountable for ensuring compliance with applicable regulations and guidelines, as well as establishing procedures and trainings to protect human subjects from research risk and ensure data integrity.
- Key Responsibilities:
- Oversight of end-to-end clinical trial activities from a quality perspective
- Accountability for ensuring compliance with applicable regulations and guidelines
- Establishing procedures and trainings to protect human subjects from research risk and ensure data integrity
Requirements
To be successful in this role, you will need:
- A minimum of 5 years' experience in a CRO/Pharma/Biotech organization in a Quality department
- Strong eye for detail and ability to spot inconsistencies
- Good conflict management skills
- Experience handling audits & inspections of DCGI, US FDA
- Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials
Preferred Skills
Experience of working in matrix business environments is preferred, as well as a strong track record of success demonstrated through annual performance ratings and/or professional accomplishments and awards.
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