Tmf Reviewer

Key Accountabilities:
Accountability
Supporting Activities
TMF Support
- 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

TMF Quality Management
- 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.

TMF Audit Support
- Takes proactive measures to prepare study for audit.
- Facilitates internal and external TMF audits.

Facilitate process and tool updates
- Collaborate with the study team and manages TMF tools customization and TMF Plan / CFMP Development and sign off

TMF Archival Preparation
- 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
- Competencies, skills and abilities:

- Good computer skills including but not limited to the knowledge of Clinical Trial Systems, eTMF systems and MS-Office products such as Excel, Word
- Data Processing and analysis skills, including management of TMF documents as per the process using different systems/tools for TMF Audit/Inspection readiness
- Ensure effective, open, timely, and collaborative written and verbal communication, with internal and on occasion external stakeholders
- Ability to successfully work in a (“virtual”) team environment: In-depth understanding of how the team integrates with others in accomplishing the objectives of the area
- Able to demonstrate basic problem solving and risk management activities
- Effective time management, prioritizing multiple tasks in order to meet daily metrics, team and project objectives
- Proactive management of work quality and the assurance of consistent delivery of high-quality outcomes, minimizing wasted effort and maximizing positive results from performed work
- Able to take initiative and work independently, seeking guidance only when necessary and escalating issues as required
- Strong internal customer focus
- Offering of support and constructive feedback to project team members
- Exhibits a sense of urgency about solving problems and completing work

Knowledge and Experience:

- Preferred experience with clinical trials, or managing documentation
- Prior experience in an international environment would be advisable.
- Strong command of written and spoken English language

**Education**:

- Bachelor’s degree preferred (or relevant clinical or business equivalent)

LI-REMOTE