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Trial Master File Specialist

Biorasi
Biorasi
2+ years
Not Disclosed
10 Dec. 11, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Trial Master File (TMF) Specialist
Location: Remote (Global)
Employment Type: Full-time
Posted: 12/11/2024

About Biorasi:

At Biorasi, we are rapidly growing and looking for passionate individuals to join our team! As an award-winning, customer-focused, full-service clinical research organization, we are committed to fostering an innovative, collaborative, and dynamic environment. We capitalize on your strengths while promoting work-life balance to help you thrive.

This is your opportunity to join a global company that is expanding within the clinical research industry. We seek top performers – whether you're a clinical trial veteran or a newcomer – to help drive new therapies to patients.

Your Role:

As a Trial Master File (TMF) Specialist, you will play a critical role in ensuring the efficient management of TMF documentation across multiple studies. Your responsibilities will include:

  • Reviewing, classifying, and processing TMF documents (both electronic and hard copy) per the TMF plan and Biorasi SOPs.
  • Supporting the setup, maintenance, closure, and transfer of TMF documentation throughout the study.
  • Escalating TMF-related issues regarding health, completeness, and document quality to functional leads.
  • Preparing and transmitting TMF and other critical documents to the Sponsor according to relevant instructions.
  • Maintaining system access control and ensuring TMF documentation is submitted and published according to study plans and in audit-ready quality.
  • Performing periodic TMF quality checks and assisting with training team members on TMF systems and requirements.
  • Planning, preparing, and presenting monthly TMF status updates, risks, issues, and actions for assigned projects.
  • Providing completeness and reconciliation reports to the project team.
  • Serving as backup to TMF Associate as needed.
  • Supporting study teams in the preparation, conduct, and follow-up of audits/inspections.
  • Managing paper file archiving and maintaining inventory.

Your Profile:

  • Education: Bachelor’s Degree in a scientific discipline or equivalent work experience in a related field.
  • Experience: Minimum of five years in clinical research with at least five years of experience in eTMF management preferred.
  • Skills:
    • Proficiency in data collection, indexing, and editing, with adherence to standardized document naming conventions.
    • Experience with the Trial Master File Reference model preferred.
    • Strong knowledge of records management best practices.
    • Proficient in MS Office (Word, PowerPoint, Excel).
    • Familiarity with International and local regulations and ICH GCP guidelines.
    • Fluent in English (both written and spoken).

Why Biorasi?

  • Employee Benefits: Enjoy half-day Fridays, paid time off, paid holidays, employee bonuses, and career growth opportunities.
  • Diversity and Inclusion: Biorasi is committed to creating a diverse and inclusive environment, ensuring equal opportunities for all applicants.

Apply Now:

If you have the experience required and want to join a dynamic and collaborative team, please apply directly on our website at Biorasi Careers or email us at careers@biorasi.com.