TMF Specialist Job at Syneos Health | Apply Now
Syneos Health, a leading biopharmaceutical solutions organization, is hiring a TMF Specialist II for a remote position in India. This role is fundamental to regulatory compliance, requiring expertise in the Trial Master File (TMF) life cycle and stringent Quality Control (QC). If you have a minimum of 18 months of demonstrable records management experience and are seeking an accelerated Syneos Health careers opportunity, apply today to join our agile team of problem solvers. You could be the TMF Specialist we’re looking for.
- Designation: TMF Specialist II
- Location: Remote (Pre-Approved) – IND-Remote
- Job Requisition ID: 25103946
About The Company
Syneos Health is built to accelerate customer success by translating unique clinical, medical affairs, and commercial insights into outcomes. We are committed to developing our people through career progression, training, and a Total Self culture. Our 29,000 employees globally work to accelerate the delivery of therapies.
Key Responsibilities
This role is central to regulatory compliance, requiring rigorous documentation management and quality control jobs expertise. As a specialist, your TMF responsibilities are crucial.
- TMF Setup & Maintenance: Support the set-up, maintenance, and closure of TMF repositories.
- Documentation Processing: Process study documentation in accordance with SOPs, WIs, GCP, and ICH guidelines.
- Quality Control (QC): Perform Quality Review of documents submitted to the TMF. Must have good experience in QC of documents as per guidelines.
- Issue Resolution: Rectify corrections, liaise with document owners to resolve issues, and follow up as per requirement. Escalate issues to the TMF Lead as required.
- Compliance: Ensure the security and compliance of all documents related to active and archived projects. Participate in TMF preparation/reconciliation for audits and inspections.
Essential Qualifications and Expertise
Success in this TMF specialist role requires foundational experience in clinical documentation:
Education & Experience
- Experience (TMF Specific): Must have 2-3 years of experience with TMF tasks typical for a Specialist.
- Records Management: Minimum of 18 months demonstrable records management experience.
- Education: Undergraduate degree and/or experience with courses in the scientific/regulatory field preferred.
- Clinical Experience: Some experience in a clinical trials environment preferred.
Core Skills
- Technical Proficiency: Proficiency in Microsoft Office Suite and Adobe Acrobat is required.
- Systems: Familiarity with an electronic TMF system preferred.
- Soft Skills: Strong verbal, written, and organizational skills. Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment.
This TMF Specialist II position offers a highly flexible Syneos Health careers path in regulatory documentation. If you have the required 18+ months of records management experience and expertise in TMF QC, apply now for this remote TMF specialist opportunity and advance your specialized skills in the field of quality control jobs.
