QC Specialist(eTMF Document Specialist)
eClinical SolutionsBengaluru, Karnataka, India
Posted May 28, 2025
Full Time
About the Company
eClinical Solutions provides a data analytics platform and biometrics services to help biopharma researchers manage trial complexity and enable faster breakthroughs.
Job Description
eClinical Solutions seeks a Trial Master File (TMF) Quality Control Specialist to ensure the accuracy, completeness, and compliance of the TMF, which is the central repository of essential documents for a clinical trial. The successful candidate will have strong knowledge of ICH-GCP guidelines, DIA TMF Reference Model, and other relevant regulatory requirements.
Requirements
- Four-year college degree or higher preferred
- Minimum 2-3 years in Pharmaceutical/Biotechnology industry or equivalent
- Excellent knowledge of English
- Strong knowledge of ICH-GCP guidelines, DIA TMF Reference Model, and other relevant regulatory requirements (e.g., FDA, EMA)
- Experience with electronic Trial Master File (eTMF) systems (e.g., Veeva, Trial Interactive)
- Ability to manage multiple priorities and work independently or as part of a team
- Excellent verbal and written communication skills
- Detail oriented, ability to multitask with strong prioritization, planning and organization skills
- Excellent team player
- Proficiency in Microsoft Office Applications, specifically MS Word, MS Excel and PowerPoint
