Research Scientist

3 days ago

Pune, Maharashtra, India Lupin Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Job Description
  • Support Head Medical Research & Head CRU in selection/procurement of Electronic Trial Master File (eTMF) & Clinical Trial Management System (CTMS) platforms which will be implemented for local India as well as Global Clinical Trials.
  • Oversee the building, implementation, maintenance, and ongoing management of TMF and CTMS systems and their associated processes. 
  • Ensure all TMF and CTMS documentation is compliant with regulatory requirements (e.g., ICH GCP) and industry best practices.
  • Develop and implement policies, standards, and work instructions for TMF and CTMS operations, identifying opportunities for continuous improvement and increased efficiency.
  • Coordinate and support internal and external audits and inspections, preparing for and responding to findings and questions. 
  • Manage quality control activities for TMF & CTMS operations, review data quality outputs, and implement corrective action plans.
  • Act as a key contact for and manage relationships with TMF and CTMS vendors. 
  • Lead and develop TMF & CTMS operations teams, ensuring proper training on systems and processes for study teams.
  • Track, manage, and report on TMF and CTMS performance metrics, identifying trends and providing action plans to senior management. 
  • Oversee document receipt, scanning, indexing, quality control, and archiving to ensure the TMF tells the complete story of the trial. 
Work Experience

Candidate with 7-8 years of experience in handling the Trial Master File (TMF) & Clinical Trial Management System (CTMS) in various platforms. Experience in working Clinical Trials in CROs or Sponsor companies. 

Education Graduation in Life Science Competencies 1. Strategic Agility 3. Customer Centricity 4. Developing Talent 6. Process Excellence 8. Stakeholder Management

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