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Trial Master File Specialist

5+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Part Time Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Summary

Biorasi, an award-winning, customer-focused clinical research organization, is looking for dedicated professionals to join their team. The company is expanding and seeks individuals passionate about clinical research, including both veterans and newcomers to the field. This role is an excellent opportunity for candidates who are eager to be part of a growing global company committed to innovative clinical trials and improving patient outcomes.

Your Role

As a Trial Master File (TMF) Specialist, you will be responsible for managing the TMF documents for multiple studies, ensuring compliance with Biorasi’s Standard Operating Procedures (SOPs) and the Trial Master File plan. Your primary tasks will include maintaining the TMF in both electronic and hard copy formats, ensuring the accuracy, completeness, and readiness of the files for audits/inspections. You will also support study set-up, structure, and transfer of TMF, and collaborate with cross-functional teams to ensure proper documentation and study operations.

Responsibilities

  • TMF Management: Review, classify, and process TMF documents in both electronic and paper formats.
  • Quality Assurance: Ensure TMF is audit/inspection-ready at all times and escalate any issues to functional leads.
  • Collaboration: Work closely with Project Managers, Clinical Trial Managers, and other departments to ensure TMF documents are submitted according to the study plan.
  • Document Control: Assist with the creation of Expected Document Lists (EDL) and ensure document naming conventions are followed.
  • Audit Support: Participate in internal and external audits, prepare TMF status reports, and assist in corrective actions.
  • Team Training: Help train team members on TMF systems and study-specific requirements.
  • Reporting: Provide reconciliation reports and TMF completeness status for project teams.
  • Archiving: Archive all paper files and maintain a list of received files.
  • Communication: Participate in project meetings and teleconferences, and report any out-of-scope issues to management.

Qualifications

  • Education: Bachelor’s degree in a scientific discipline or sufficient related work experience.
  • Experience: Minimum of 5 years in clinical research, with at least 5 years of experience in eTMF management preferred.
  • Skills:
    • Data collection, indexing, and editing with adherence to standardized naming conventions.
    • Experience with the Trial Master File Reference model preferred.
    • Knowledge of records management best practices.
    • Proficiency in MS Office Suite (Word, PowerPoint, Excel).
    • Understanding of ICH GCP guidelines, and local regulations.
    • Fluency in English (oral and written), and applicable local language.

Compensation and Benefits

Biorasi offers a comprehensive benefits package, including:

  • Flexible work hours with half-day Fridays.
  • Paid Time Off (PTO), paid holidays, and extensive country-specific benefits.
  • Employee Bonus Programs.
  • Career Growth: Opportunities for training and development.
  • Health and Well-being: Thoughtfully designed benefits for employees and their families.

Why Biorasi?

Biorasi is committed to maintaining an innovative, collaborative, dynamic, and evolving work environment. The company values work-life balance and strives to capitalize on employees' strengths while encouraging personal growth. As a diverse, equal opportunity employer, Biorasi fosters an inclusive environment where all qualified applicants are considered without regard to race, gender, religion, or other protected characteristics.

What to Expect Next

If your qualifications match the role, you will be contacted for the next steps in the hiring process, which may include interviews and further assessments.

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