Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. With a global workforce of 29,000 employees across 110 countries, Syneos Health translates clinical, medical affairs, and commercial insights into actionable outcomes.
The company fosters a “Total Self” culture, encouraging employees to bring their authentic selves to work while promoting diversity, inclusion, and career growth. Recognized for its innovation, Syneos Health has collaborated with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, managing over 200 studies across 73,000 sites and 675,000+ trial patients.
Job Description: Intern (Clinical Operations & TMF Management)
Key Responsibilities
As an Intern at Syneos Health, you will support clinical operations with a focus on Trial Master File (TMF) management and administrative tasks. Your role will include:
✔ TMF Document Management
- Assist in maintaining the Trial Master File (TMF) by preparing, submitting, and organizing documents.
- Ensure compliance with ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate).
- Perform quality checks on documents and resolve discrepancies with project teams.
✔ Study Support & Administrative Tasks
- File study-related documents (CVs, correspondence, monitoring reports).
- Manage helpdesk tickets for system access (EDC, CTMS).
- Enter site information into the Clinical Trial Management System (CTMS).
- Prepare IRB application forms and assist in safety report submissions.
- Support investigator fee payments and document translation processes.
✔ Cross-functional Collaboration
- Work with global teams to understand different job scopes.
- Assist in data collection, analysis, and report generation.
- Support logistics for departmental and external meetings.
Qualifications & Skills Required
- Education: Degree in biological sciences, healthcare, or related fields (preferred).
- Experience: Prior administrative or clinical research exposure is a plus.
- Technical Skills: Proficiency in Microsoft Office (Word, Excel, PowerPoint) and familiarity with eTMF/CTMS systems.
- Soft Skills:
- Strong communication & time management.
- Ability to multitask in a fast-paced environment.
- Detail-oriented with a problem-solving mindset.
- Language: Fluency in English (written & verbal).
Why Join Syneos Health?
✅ Career Growth: Continuous learning with training & development programs.
✅ Global Exposure: Collaborate with teams across 110 countries.
✅ Inclusive Culture: A workplace that values diversity & inclusion.
✅ Impactful Work: Contribute to cutting-edge clinical trials that improve patient lives.
