Research Scientist - Medical Research

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

Competencies