Job Purpose:
A Trial Master File Reviewer (TMF Reviewer) has proficient knowledge about PAREXEL or Sponsor specific Electronic Trial Master File (eTMF) and paper documents management processes and procedures.
The TMF Reviewer contributes to the assigned tasks within the project, displaying a good understanding of TMF processes, as well as efficiency, accuracy and quality. Achieves department’s overall business objectives and works closely with other levels within Records Management and under LM supervision to meet project requirements. Depending on the location and assignments, the role of a TMF Reviewer may include document processing where specifically contracted for this task, completeness checks / milestone reviews, or other activities as defined in Parexel procedures and client requirements.
Key Accountabilities:
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
- Good understanding of procedures and concepts within own technical/subject area and a proficient knowledge in other related areas.
- 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)