Clinical Research Job for Freshers | Apply Now for the Executive Role at Sun Pharma
Sun Pharma Laboratories Ltd. is seeking an Executive – Trial Master File (eTMF Executive) to join its Clinical Research Business Unit, based at the Corporate Office in Mumbai. This Clinical Research Job is ideal for fresh graduates or those with up to 2 years of experience in Clinical Research. The eTMF Executive will be responsible for the accuracy, completeness, and regulatory compliance of all trial-related documents, maintaining the eTMF system, performing periodic TMF gap analysis, and ensuring the system is continuously inspection-ready for health authorities.
- Job Title: Executive – Trial Master File
- Location: Mumbai
About The Company
Sun Pharma Laboratories Ltd. is a subsidiary of Sun Pharmaceutical Industries Ltd., a multinational pharmaceutical company and one of the largest in India, with a significant global presence. Sun Pharma is committed to providing affordable, high-quality medicines and driving innovation. The company’s Clinical Research unit operates under stringent compliance standards, ensuring meticulous management of clinical trial documentation via the Trial Master File (TMF). Sun Pharma emphasizes a culture of continuous growth, collaboration, and operational excellence to make a lasting impact on global health, including the development of a robust clinical research job sector.
Educational Qualifications for the Executive Job
- Minimum qualification requirement is to have a Bachelor’s or Master’s degree in a health-related field, such as pharmacy, or public health, and/or a Post-graduate Diploma in Clinical Research.
Experience
- Relevant experience of 0-2 years minimum in the field of clinical research, crucial for progressing in clinical research jobs.
Responsibilities of the Executive Job
1. Documentation and Administrative Support:
- Ensuring all trial-related documents are organized, accurate, and complete.
- Reviewing and approving documents for quality and compliance.
- Maintaining version control for all documents in your clinical research job role.
2. System Oversight:
- Maintaining the eTMF system, ensuring it’s up-to-date and functioning correctly.
- Establishing and maintaining the eTMF’s structure and folder system.
3. Regulatory Compliance Support:
- Ensuring the eTMF system is inspection-ready for health authorities.
- Serving as the point of contact for auditors during inspections for TMF related queries.
4. Process Improvement:
- Continuously evaluating and improving the eTMF processes and workflows to increase efficiency and compliance, vital for a successful clinical research job.
5. Coordination & Communication:
- Coordination and follow-up with CRAs to update TMF.
- Perform periodic TMF gap analysis and communicate the insufficiency to CRAs, a key part of clinical research job responsibilities.
