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    Trial Master File Specialist

    Biorasi
    5+ years
    Not Disclosed
    Mumbai
    10 Dec. 24, 2024
    Job Description
    Job Type: Full Time 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 Opportunity: TMF Specialist
    Location: Flexible (Remote/On-site options available)

    About Biorasi
    At Biorasi, we are driving innovative change in clinical research. Join our collaborative, dynamic, and evolving team where we value work-life balance and career growth. As an award-winning, customer-focused, full-service clinical research organization, we are looking for passionate individuals to help us bring life-changing therapies to patients.

    Your Role

    As a TMF Specialist, you will be a key contributor to maintaining audit- and inspection-ready Trial Master Files (TMF) for multiple studies. Responsibilities include:

    • Document Processing and Management:
      • Review, classify, and process TMF documents in electronic and hard copy formats per TMF plan and SOPs.
      • Support study setup, structure, maintenance, closure, and transfer of TMF.
      • Prepare the Expected Document List (EDL) in the eTMF system and maintain system access control.
    • Monitoring and Reporting:
      • Perform periodic TMF quality checks and provide completeness and reconciliation reports.
      • Escalate issues regarding TMF health, completeness, or quality to Functional Leads.
      • Plan, prepare, and present monthly TMF status, risks, and associated actions for assigned projects.
    • Collaboration and Support:
      • Assist project teams with TMF documentation submission and ensure high-quality compliance with audit/inspection standards.
      • Attend internal project team and sponsor teleconferences.
      • Support training of team members on TMF systems and study-specific requirements.
      • Act as a backup to the TMF Associate when needed.
    • Audit and Inspection Readiness:
      • Support study teams in the preparation, conduct, and follow-up of internal/external audits or inspections.
      • Archive paper files and maintain an inventory list of received files.
    • Other Duties:
      • Identify and communicate out-of-scope issues to upper management.
      • Participate in regular team meetings and teleconferences.

    Your Profile

    • Education and Experience:
      • Bachelor’s degree in a scientific discipline or equivalent experience.
      • Minimum five years of experience in clinical research, with at least five years in eTMF management.
    • Skills and Knowledge:
      • Proficiency in data collection, indexing, and document editing.
      • Familiarity with the Trial Master File Reference Model and records management best practices.
      • Strong understanding of ICH GCP guidelines and international/local regulations.
      • Proficiency in MS Office Suite (Word, PowerPoint, Excel).
    • Personal Attributes:
      • Strong attention to detail and organizational skills.
      • Excellent verbal and written communication in English.

    Why Join Biorasi?

    We prioritize the well-being of our employees and offer thoughtfully designed benefits, including:

    • Half-day Fridays.
    • Paid time off, holidays, and extensive country-specific benefits.
    • Medical, dental, and vision insurance.
    • Life insurance, short-term and long-term disability coverage.
    • Employee bonus programs and a company-matching 401(k).
    • Tuition reimbursement and professional development opportunities.

    Apply Now

    If you’re ready to join a team where your expertise will make an impact, apply directly on our Careers Page or email us at careers@biorasi.com.

    Diversity and Inclusion

    Biorasi is committed to creating an inclusive work environment. We are an equal opportunity employer and welcome applicants regardless of race, color, religion, gender identity, sexual orientation, national origin, genetics, disability, age, or veteran status. We comply with all fair employment practices regarding citizenship and immigration status.

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