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Biorasi

5 Years

Hybrid, Mumbai

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

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Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

Biorasi is a dynamic and award-winning full-service clinical research organization (CRO) dedicated to bringing new therapies to patients. As a global leader in the clinical research industry, Biorasi is known for its innovative, collaborative, and evolving approach to clinical trials. We prioritize work-life balance while supporting the professional growth of our team members. If you’re passionate about clinical research and thrive in a fast-paced, customer-focused environment, Biorasi is the perfect place for you.

Responsibilities in the Role

As a Trial Master File (TMF) Specialist, you will play a vital role in maintaining the integrity and accuracy of essential clinical trial documents. Your key responsibilities will include:

  • Reviewing, classifying, and processing TMF documents in electronic and hard copy formats according to the TMF plan and Biorasi SOPs.
  • Supporting study setup, structure, maintenance, closure, and transfer of TMF.
  • Escalating TMF-related issues to Functional Leads and assisting in providing re-training to project teams when necessary.
  • Preparing and transmitting critical documents to Sponsors in accordance with relevant instructions.
  • Setting up and maintaining the Expected Document List (EDL) in the eTMF system.
  • Controlling system access throughout the study.
  • Assisting functional leads in ensuring high-quality TMF documentation that meets audit and inspection readiness standards.
  • Conducting periodic TMF quality checks and presenting monthly TMF status, risks, and associated actions.
  • Assisting with internal and external audits/inspections and archiving paper files while maintaining accurate inventory lists.

Qualifications

We are looking for a candidate who meets the following criteria:

  • Bachelor’s Degree in a scientific discipline or equivalent work experience.
  • Fluent in English (oral and written), with proficiency in applicable local languages.
  • Minimum five years of experience in clinical research, with at least five years in eTMF management preferred.
  • Strong data collection, indexing, and editing skills, adhering to standardized document naming conventions.
  • Familiarity with the Trial Master File Reference Model is a plus.
  • Knowledge of records management best practices.
  • Proficiency in MS Office Suite (Word, PowerPoint, and Excel).
  • In-depth knowledge of international, local regulations, and ICH GCP guidelines.

Key Skills

  • Strong organizational and time-management skills.
  • Attention to detail and ability to maintain accuracy in a high-pressure environment.
  • Excellent communication and collaboration skills.
  • Problem-solving and critical thinking abilities.
  • Technical proficiency in eTMF systems and document management software.

Why Join Biorasi?

Biorasi offers an employee-centric environment designed to enhance your health and well-being. Benefits include:

  • Half-day Fridays for a better work-life balance.
  • Paid time off and paid holidays.
  • Extensive country-specific benefits.
  • Employee bonus programs.
  • Career growth, training, and development opportunities.
  • Commitment to diversity and equal employment opportunities.

Application Link

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