Are you a detail-oriented and organized individual with experience in clinical trials and document management? Syneos Health is hiring a TMF Specialist II to join their team in a remote capacity! 🌐
About the Role 📝
As a TMF Specialist II, you will play a critical role in ensuring that the company’s Trial Master File (TMF) is accurate, complete, and compliant with regulatory requirements. Your responsibilities will include:
- Document Management: Process study documentation in accordance with applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines, and executed study-specific processes/requirements.
- Quality Review: Perform Quality Review of documents submitted to the TMF and liaise with document owners to resolve any issues identified.
- TMF Repository: Support the set-up, maintenance, and closure of TMF repositories.
- Compliance: Ensure the security and compliance of all documents related to active and archived projects.
Requirements 📚
- Education: Undergraduate degree and/or experience with courses in the scientific/regulatory field preferred.
- Experience: Minimum of 18 months demonstrable records management experience.
- Skills: Strong verbal, written, and organizational skills with a team-oriented approach.
- Familiarity with Electronic TMF System: Familiarity with electronic TMF system preferred.
- Knowledge of Regulations: Some knowledge of applicable regulations and guidelines with respect to regulatory documents and familiarity with medical terminology preferred.
What We Offer 🌟
- Remote Work: Opportunity to work remotely with a flexible schedule.
- Career Growth: Opportunities for career growth and professional development.
- Collaborative Team: Work with a team of passionate problem solvers who are dedicated to delivering high-quality results.
- Total Self Culture: Syneos Health is committed to creating a culture where everyone can be their authentic self.
Benefits of Working with Syneos Health 🌟
- Meaningful Work: Opportunity to work on projects that have a meaningful impact on people’s lives.
- Career Development: Opportunities for career growth and professional development.
- Diverse and Inclusive Culture: Syneos Health is committed to creating a culture that values diversity and inclusion.
How to Apply 📧
Tips for TMF Specialists 📝
- Develop Strong Organizational Skills: Develop strong organizational skills to manage multiple tasks and prioritize deadlines.
- Stay Up-to-Date: Stay current with the latest developments and trends in TMF and clinical trials.
- Build a Strong Network: Build a strong network of contacts in the industry to stay informed and learn from others.
I have completed my graduation in B pharmacy I have 1 year experience in Sitec Cipla
Thank you for sharing your background!
With a B.Pharm degree and 1 year of experience at Sitec (Cipla), you already have a strong foundation for roles in eTMF, Clinical Research, Regulatory Affairs, PV, and QA/QC.
We recommend keeping an eye on our latest job updates—your profile aligns well with several entry-level and mid-level openings in the pharmaceutical and clinical operations domain.
If you’re exploring new opportunities, feel free to stay connected with us for upcoming relevant roles.
Wishing you the best in your job search!