Clinical Document Specialist II
TransPerfect · Pune, Maharashtra, India (On-site)
Job Type: Full-time | Experience Level: Associate
About the Role:
As a Clinical Document Specialist II, you will be responsible for ensuring the quality and accurate filing of indexed documents in the electronic Trial Master File (eTMF), applying proper metadata, and preparing the eTMF for inspection readiness. This role demands attention to detail, an understanding of TMF management regulations, and strong timeline management skills. You’ll also need knowledge of global IRBs, Regulatory authorities, and their requirements. The position is supported by a dedicated learning and development team.
Key Responsibilities:
- Review documents in workflows and finalize indexing.
- Sustain quality thresholds and meet daily productivity goals.
- Identify and correct mis-filings, provide feedback to the indexing team.
- Manage project documentation and ensure alignment with client expectations.
- Perform internal eTMF reviews and prepare corrective actions for audit readiness.
- Assist with User Acceptance Testing during product development.
Qualifications:
- Bachelor’s degree from a 4-year college or equivalent.
- Minimum 2.5 years of experience in the Life Sciences industry.
- Experience with clinical trial documentation, IRB submissions, and pharmacovigilance (preferred).
- Knowledge of clinical development phases, GCP, ICH regulations.
- Proficiency in Microsoft Office, eClinical technologies, document management tools (Adobe, ISI Tools, Capture Perfect).
Skills:
- Strong communication skills in English.
- Ability to multitask in a fast-paced environment.
- Work effectively with diverse backgrounds and cultures.
- Ability to work independently and in a team.
- Problem-solving and commitment to high service levels.
Work Shift: 9:30 AM – 6:30 PM (Work from Office)
Location: Aundh, Pune, Maharashtra, India
If interested, send your resume to skalashetti@transperfect.com
