TMF Reviewer

A TMF (Trial Master File) 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.QualificationsCompetencies, 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)