Trial Master File Specialist

2+ years

Not Disclosed

Mumbai

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.

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Trial Master File Specialist

Job Description

About Biorasi:

Your Role:

Your Profile:

Why Biorasi?

Apply Now:

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