Trial Master File Specialist

We are Growing! Let us support your career journey the Biorasi way.  Innovative, Collaborative, Dynamic and Evolving.  Capitalizing on your strengths while encouraging work-life balance.  Biorasi is an award-winning, customer-focused, full-service clinical research organization.

Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

Your role:

• Review, classify, and process Trial Master File (TMF) documents for multiple studies both in an electronic and hard copy format in a timely manner per the TMF plan and Biorasi SOPs
• Support for study et-up, structure, maintenance, closure, and transfer of TMF.
• Escalate any TMF related observations/issues regarding TMF health/status, including actionable metrics, completeness, and quality of documents electronic in a timely manner to Functional Leads. As necessary, support in providing re-training to the project team.
• Prepare and transmit TMF and other critical documents to the Sponsor in accordance with the relevant instructions.
• Prepare initial set up of Expected Document List (EDL) in eTMF System.
• Maintain System Access control throughout the study
• Assist the Project Manager, Clinical Trial Manager, and other functional leads (e.g., data management; biostats; medical writing, supply chain, etc.) to ensure TMF documentation is submitted/published according to study plan and with high quality in order to maintain TMF in an audit/inspection-ready state.
• Perform periodic TMF quality check as per SOP
• Attend internal project team and sponsor teleconferences as applicable to the project.
• Assist in training team members on TMF systems and study specific requirements.
• Plan, prepare and present monthly TMF status, risks, issues, and associated actions for assigned projects.
• Provide completeness & reconciliation reports to the project team
• May serve as back-up to TMF Associate
• Support the study team in the preparation, conduct, and follow up of internal and/or external audits/inspections.
• Archive all paper files and maintain an ongoing inventory list of all received files in timely manner.
• Partake in regular team meeting / teleconferences.
• Communicate any out-of-scope issues to upper management as soon as identified.
• Other duties as assigned.  

Your Profile:

• Bachelor’s Degree in scientific discipline; or sufficient work experience in related field
• Fluent English (oral and written) and applicable local language.
• Minimum five years of experience in clinical research. At least five years of experience in eTMF management preferred.
• Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions
• Experience with the Trial Master File Reference model preferred
• Understanding of records management best practices
• Knowledge and experience with MS Office suite (Word, PowerPoint, and Excel)
• Knowledge of International, local regulations and ICH GCP guidelines.

We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being.  Our employees enjoy half-day Fridays, paid time off, paid holidays, extensive country specific benefits, employee bonus programs, career growth, training and development.

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.