Records Specialist I – Premier Research Careers in Bangalore
Are you passionate about contributing to life-changing medical innovations? Premier Research, a global leader in clinical research, is seeking a Records Specialist I to join our Pharmacovigilance and Records Management team in Bangalore, India. This is a full-time, office-based opportunity to work with a company dedicated to transforming breakthrough science into new medicines, devices, and diagnostics.
About Premier Research
At Premier Research, we are Built for Biotech™. Our mission is to help biotech, medtech, and specialty pharma companies bring life-saving treatments to patients worldwide. We recognize that our team members are our most valuable asset, and we are committed to providing a supportive environment where you can grow, excel, and achieve a healthy work-life balance.
Your Role as a Records Specialist I
As a Records Specialist I, you will play a critical role in ensuring the efficient management of clinical trial records. Your responsibilities will include:
- Performing all departmental budgeted activities for assigned studies.
- Assisting with identifying, reporting, and resolving quality and efficiency concerns in records management practices.
- Understanding TMF Plans, TMF indexes, and transition plans for assigned studies.
- Supporting live, web-based, and recorded training sessions for company staff, sponsors, and third parties.
- Assisting with internal and external audits and inspections globally.
- Managing office-based and off-site corporate archives as needed.
- Demonstrating systems and participating in study kick-off meetings (KOMs) and project team meetings.
- Performing eTMF System Administrator responsibilities when required.
- Completing additional duties as assigned by the TMF Lead or department management.
What We Are Looking For
To excel in this role, you should have:
- Previous experience in clinical trials records management (preferred).
- Familiarity with computerized clinical trials records management technologies (preferred).
- Knowledge of global clinical trials and the pharmaceutical/medical device industry (preferred).
- Proficiency in web-based communication tools and IT systems.
- A basic understanding of ICH-GCP, ISO14155, and global regulations related to Trial Master File (TMF) management.
Why Join Premier Research?
- Built for You: We provide the skills, opportunities, and flexibility you need to grow professionally while maintaining a balanced life.
- Built by You: Your ideas and voice matter here. You’ll have the chance to influence how we work and contribute to our success.
- Built with You: As part of our team, you’ll help deliver the medical innovations that patients desperately need.
