Biorasi is a dynamic and award-winning full-service clinical research organization (CRO) dedicated to bringing new therapies to patients. As a global leader in the clinical research industry, Biorasi is known for its innovative, collaborative, and evolving approach to clinical trials. We prioritize work-life balance while supporting the professional growth of our team members. If you’re passionate about clinical research and thrive in a fast-paced, customer-focused environment, Biorasi is the perfect place for you.
Responsibilities in the Role
As a Trial Master File (TMF) Specialist, you will play a vital role in maintaining the integrity and accuracy of essential clinical trial documents. Your key responsibilities will include:
- Reviewing, classifying, and processing TMF documents in electronic and hard copy formats according to the TMF plan and Biorasi SOPs.
- Supporting study setup, structure, maintenance, closure, and transfer of TMF.
- Escalating TMF-related issues to Functional Leads and assisting in providing re-training to project teams when necessary.
- Preparing and transmitting critical documents to Sponsors in accordance with relevant instructions.
- Setting up and maintaining the Expected Document List (EDL) in the eTMF system.
- Controlling system access throughout the study.
- Assisting functional leads in ensuring high-quality TMF documentation that meets audit and inspection readiness standards.
- Conducting periodic TMF quality checks and presenting monthly TMF status, risks, and associated actions.
- Assisting with internal and external audits/inspections and archiving paper files while maintaining accurate inventory lists.
Qualifications
We are looking for a candidate who meets the following criteria:
- Bachelor’s Degree in a scientific discipline or equivalent work experience.
- Fluent in English (oral and written), with proficiency in applicable local languages.
- Minimum five years of experience in clinical research, with at least five years in eTMF management preferred.
- Strong data collection, indexing, and editing skills, adhering to standardized document naming conventions.
- Familiarity with the Trial Master File Reference Model is a plus.
- Knowledge of records management best practices.
- Proficiency in MS Office Suite (Word, PowerPoint, and Excel).
- In-depth knowledge of international, local regulations, and ICH GCP guidelines.
Key Skills
- Strong organizational and time-management skills.
- Attention to detail and ability to maintain accuracy in a high-pressure environment.
- Excellent communication and collaboration skills.
- Problem-solving and critical thinking abilities.
- Technical proficiency in eTMF systems and document management software.
Why Join Biorasi?
Biorasi offers an employee-centric environment designed to enhance your health and well-being. Benefits include:
- Half-day Fridays for a better work-life balance.
- Paid time off and paid holidays.
- Extensive country-specific benefits.
- Employee bonus programs.
- Career growth, training, and development opportunities.
- Commitment to diversity and equal employment opportunities.