Precision for Medicine is a fully integrated clinical research organization (CRO) specializing in biomarker-informed therapeutic and diagnostic development programs. The organization connects multiple data streams from sites, central labs, and specialty labs, helping clients make data-driven decisions that directly impact patient health. Precision excels at merging personalized clinical services with scientific expertise to meet the challenges of complex global trials.
Position Summary
The Documents Specialist II will manage essential documentation for clinical studies, ensuring quality, compliance, and organization within the electronic Trial Master File (eTMF). The specialist will oversee document quality control, indexing, monitoring of submissions, and the close-out of studies in accordance with regulatory guidelines, Good Clinical Practice (GCP), and Precision’s Standard Operating Procedures (SOPs).
Key Responsibilities
- Prepare TMF plans, conduct quality checks (QC), and index documents in alignment with GCP, ICH-E6, and regulatory guidelines (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives).
- Monitor document submissions to avoid backlogs; escalate issues to eTMF management when needed.
- Distribute TMF metrics and follow up on clarifications to ensure timely resolution.
- Manage study close-out activities, ensuring the timely submission and processing of final documents.
- Coordinate eTMF exports and ensure smooth transfer of documents to clients, including obtaining Acknowledgements of Receipt.
Qualifications
- Bachelor’s degree or equivalent combination of education and experience, preferably in business, healthcare, or a scientific discipline.
- Minimum 5 years of clinical trial experience, with at least 3 years of experience working with TMF/eTMF systems.
Essential Skills
- Proficiency in Microsoft Office applications (Outlook, Word, Excel, PowerPoint).
- Strong communication skills in English, both verbal and written.
- Familiarity with ICH-GCP guidelines, Precision’s SOPs, and other relevant regulatory standards.
Competencies
- Detail-oriented with solid interpersonal and organizational skills.
- Able to work independently and in team settings, maintaining professionalism and punctuality.
- Self-motivated, dependable, and committed to delivering high-quality work.
- Strong alignment with Precision for Medicine’s values and principles.
How to Apply
If you meet the qualifications and are excited to contribute to the advancement of precision medicine, apply directly on-site or through the Easy Apply option available for this job. Ensure your resume reflects your relevant clinical trial and document management experience.
