Key Accountabilities:
TMF Support
- Collaborates with the TMF Inspection Readiness Specialist to plan and execute assigned tasks.
- Maintains an 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 feedback to PS/FL Super Users in CRS Technology to enable enhanced systems, tools, and processes.
TMF Quality Management
- Maintains the TMF for ongoing studies according to PAREXEL SOPs or contractual obligations to the 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 the project’s TMF tasks.
- Understands how their role and expertise impact TMF quality and timeliness.
TMF Audit Support
- Takes proactive measures to prepare the study for audit.
- Facilitates internal and external TMF audits.
Facilitate Process and Tool Updates
- Collaborates 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 the 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 the 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 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.