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Tmf Reviewer

3 weeks ago

Remote, India Parexel Full time

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. This individual also:

- 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
- Processes documents, where specifically contracted for this task, completeness checks / milestone reviews, or other activities as defined in Parexel procedures and client requirements.

**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