Position Summary:

The Quality Review Specialist is responsible for performing periodic TMF Quality Reviews for assigned projects in a timely manner and with high quality. The Quality Reviews are used to evaluate the completeness status of study TMFs and are critical to ensuring TMFs are maintained in an audit-ready manner. The Quality Review Specialist will be assigned responsibility for the less complex and/or smaller studies in the Precision portfolio.

Essential functions of the job include but are not limited to:
- Performs periodic TMF Quality Reviews for assigned projects in a timely manner and with high quality
- Ensures that TMF documentation related to periodic TMF Quality Reviews is generated and filed in the TMF.
- Informs the TMF Lead if the TMF is not updated with the information related to countries, sites, contacts and applicable TMF document requirements.
- Supported by Manager, monitors and escalates to the TMF Lead document processing issues and inconsistences, missing/incorrect documents filed by the Functional Leads,



non-response of the Functional Leads related to periodic Quality Review requests or questions.
- During periodic Quality Reviews, supports updates to expected documents and opening of placeholders in TMF, where needed.
- Where possible, identifies potential training needs for all team members working in the TMF to encourage high quality and consistent maintenance of the TMF.
- Supported by Manager, identifies and escalates to TMF leadership studies at responsible risk based on poor quality.

Qualifications:

Minimum Required:
- Bachelor’s degree (or its international equivalent) + 2 years of related experience

Other Required:
- Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
- Experience with eTMF systems and vendors
- Working knowledge of FDA & ICH/GCP regulations and guidelines

Skills:
- Demonstrates solid interpersonal skills
- Ability to identify issues and escal

📌 Quality Review Specialist (Bengaluru)
🏢 Precision Medicine Group
📍 Bengaluru