Temporary TMF Document Administration Assistant Flexible Working
- Experience Level
- Experienced (non-manager)
Temporary TMF Document Assistant - Flexible working
UK - Home Based
Here at Syneos Health we are currently looking for tech savvy new team members, ideally with a healthcare background (not essential) to join our large TMF team, working home-based, on hourly rate, 20 hours per week.
The TMF Document Assistant performs quality control (QC) review on Clinical Trial documentation according to Standard Operating Procedures (SOPs)/Work Instructions (WIs) and Trial Master File (TMF) Plans for assigned studies within the electronic TMF (eTMF) system. Identifies any quality issues with the documentation and follows the appropriate query process to have the quality issue resolved.
Your role as a TMF Document Assistant would include the following responsibilities:
• Perform thorough QC of documents for assigned studies according to applicable study specific requirements and SOPs/WIs.
• Identify quality issues as applicable and address minor corrections and issue queries to the TMF Contributors.
• Follow-up with TMF Contributors to obtain resolution to queries.
• Review/update/add metadata within the eTMF system to documents, as applicable.
• Participate in project-specific training, as assigned.
- High school education, some college courses in the scientific/regulatory field preferred.
- Some experience in a clinical trials environment preferred.
- Strong knowledge of all applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology.
- Very high attention to detail in reviewing electronic documents.
- Strong verbal, written, and organizational skills with a team-oriented approach.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
- Confidence in working independently and remotely using multiple electronic applications.
- Equipped with reliable internet access and personal computer/laptop.
- Proficiency in Microsoft Office Suite and email.
- Ability to meet via WebEx /webcam on a weekly basis.
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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