Title:  Executive - Trial Master File

Job Title:

eTMF Executive

Business Unit:

Clinical Research

Location:

Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

TASKS AND RESPONSIBILITIES:

• 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.

• 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.

• 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.

• Process Improvement:

• • Continuously evaluating and improving the eTMF processes and workflows to increase efficiency and compliance.

• Coordination & Communication:
  • Coordination and follow-up with CRAs to update TMF
  • Perform periodic TMF gap analysis and communicate the insufficiency to CRAs

Job Requirements

Educational Qualification

Minimum qualification requirement is to have a Bachelor's or Master’s degree in a health-related field, such as biology, chemistry, nursing, pharmacy, or public health and/or Post-graduate Diploma in Clinical Research.

Experience

Relevant experience of 0-2 years minimum in the field of clinical research.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).