Tmf Reviewer

India, Remote

**Job ID** R0000016952

**Category** Clinical Trials

**ABOUT THIS ROLE**:

- Collaborates with the TMF Inspection Readiness Specialist to plan and execute assigned tasks.
- Maintains overview of the agreed planning, proactively providing status updates and notifying trends to the study team and TMF IR Specialist.
- Stays flexible and always looks for proactive, responsible solutions to ensure client satisfaction.
- Provides feed-back to PS/FL Super Users in CRS Technology in order to enable enhanced systems, tools and processes.
- Maintains the TMF for ongoing studies according to Parexel SOP’s or contractual obligation to sponsor, by performing completeness checks/ milestone reviews or other TMF contracted tasks according to the established timelines and quality criteria.
- Proactively cooperates with LM and FLs on project’s TMF tasks.
- Understands how their own role and expertise impact TMF quality and timeliness.
- Takes proactive measures to prepare study for audit.
- Facilitates internal and external TMF audits.Participates in the TMF closure process as required by Sponsor and Parexel Procedures
- Prepares eCRF CDs and participates in eCRF process as defined in the relevant manuals and SOPs
- Collaborate with the study team and manages TMF tools customization and TMF Plan / CFMP Development and sign off

LI-REMOTE