TMF Specialist I

TMF Specialist I

inVentiv Health Clinical SRE, LLC
Malaysia
Not Specified
Not Specified

Job Description


Job Description :
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.
JOB SUMMARY
Performs support tasks related to the set-up, maintenance and close out of the Trial Master File.
JOB RESPONSIBILITIES
  • Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans.
  • Support the set-up, maintenance, and closure of TMF repositories.
  • Support documentation collection activities, including: Document scanning and indexing for trial using an electronic TMF
  • Document filing for trials using a paper TMF
  • Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified
  • Maintain compliance with departmental quality, performance and utilization targets
  • Complete administrative tasks (e.g., status reports) as requested
  • Maintain compliance with company requirements (e.g., time tracking, training)
  • Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipments.
  • Participates in study specific training as required.
  • For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room
  • Ensures the security and compliance of all documents related to active and archived projects
  • Performs other work-related duties as assigned. Occasional travel may be required (up to 10%).
Qualifications
QUALIFICATION REQUIREMENTS
High school education, some college courses in the scientific/regulatory field preferred. Some experience in a clinical trials environment preferred. Some knowledge of applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology preferred. Familiarity with electronic TMF system preferred. Strong verbal, written and organizational skills with a team-oriented approach. Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment. Proficiency in Microsoft Office Suite and Adobe Acrobat.
Disclaimer:
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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