Clinical Document Specialist II at Transperfect
Position Name: Clinical Document Specialist II
Organization: Transperfect
Location: Aundh, Pune, Maharashtra, India
Experience: 1 to 2 Years
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Salary: ₹25,000 – ₹35,000 /month
Job Type: Full-time | On-site
Work Shift: 9:30 AM – 6:30 PM
Job Overview
Transperfect, a global leader in language and technology solutions, is seeking a Clinical Document Specialist II for its office in Pune. This role involves managing, reviewing, and ensuring the quality of documents within the electronic Trial Master File (eTMF) system. The successful candidate will have strong attention to detail, knowledge of clinical trial documentation, and be able to manage timelines effectively. You’ll work closely with a dedicated learning and development team to ensure compliance with global IRB and regulatory authority standards.
Key Responsibilities
As a Clinical Document Specialist II, you will be responsible for:
- Document Review & Indexing: Review documents in workflows, finalize their indexing in the eTMF, and ensure proper metadata tagging.
- Quality Management: Maintain high-quality standards, meeting daily productivity goals and ensuring compliance with Good Clinical Practice (GCP) and ICH regulations.
- Misfiling Correction: Identify and rectify mis-filings, providing feedback to the indexing team.
- Project Documentation: Manage project documentation to meet client expectations and timelines.
- Audit & Inspection Readiness: Perform internal reviews, manage corrective actions for audit preparation, and ensure eTMF is always ready for inspection.
- User Acceptance Testing: Assist with UAT (User Acceptance Testing) during product development phases.
Required Qualifications
| Qualification | Details |
|---|---|
| Degree | Bachelor’s degree in pharmaceutical or life sciences-related fields such as B.Pharm, M.Pharm, Pharm.D, or MSc. |
| Experience | 1-2 years of experience in the Life Sciences industry, with knowledge of clinical documentation processes. |
| Preferred | Experience in clinical trial documentation, IRB submissions, and pharmacovigilance. |
Skills Required
- Document Management: Proficiency in Microsoft Office, eClinical technologies, and document management tools like Adobe, ISI Tools, and Capture Perfect.
- Knowledge of Clinical Phases: Familiarity with clinical development phases and regulatory requirements.
- Communication: Strong English communication skills, both written and verbal.
- Problem Solving: Ability to handle issues independently and as part of a team.
- Multitasking: Ability to handle multiple tasks in a fast-paced environment while maintaining high service levels.
Why Join Transperfect?
At Transperfect, you will work in a collaborative and diverse environment, focusing on managing crucial clinical documentation for global trials. You will gain hands-on experience in managing regulatory submissions, working alongside industry professionals, and contributing to impactful healthcare projects.
- Global Impact: Work with clinical documentation that supports global research initiatives.
- Learning Opportunities: A dedicated learning and development team supports your growth within the industry.
- Diverse Team: Collaborate with professionals from varied backgrounds and cultures.
How to Apply
Interested candidates are encouraged to apply by sending their resume to skalashetti@transperfect.com. For more details, visit Transperfect Careers.
Join Transperfect as a Clinical Document Specialist and contribute to the advancement of healthcare research while developing your expertise in clinical documentation.
