Rahul Nirmala

Experience

• 

  CRC

  Jan 2009 - Jan 2009

  CRC@ ATRCC
• 

  Altree Lab

  Jan 2009 - Jan 2009

  Trainee CRC
• 

  Excel Life Sciences Pvt. Ltd.

  Oct 2009 - May 2011

  Lead Clinical Research Coordinator

  SD filling, patient scheduling, site start up activities, In-house activities, eCRF & paper CRF filling, EC Initial submission, ICMR/HMSC submission, conduction site feasibility, trial feasibility, DCGI dossier preparation etc

• 

  Apothecaries Clinical Research

  Jun 2011 - Mar 2014

  Project Coordinator

  Identification of sites, project coordination, site management.

• 

  ICON plc

  Apr 2014 - Sept 2022

  Maintaining a complete, compliant and consistent TMF, acts as TMF SME, ensuring TMF inspection readiness, on-boarding of new TMF Leads, conducting TMF training to sponsors and auditors Act as PM for Trial Master File. By liaising with study team ensure a complete, consistent and compliant eTMF. Drive the eTMF health metrics across functional lines. Be the single point of contact for Sponsor and clinical operations team with regards to eTMF. Support study team during audit/inspection of study TMF. Electronic Trial Master File (eTMF) management, team management, team training, process improvements.

  • Senior Trial Master File Lead

    Apr 2021 - Sept 2022

  • Trial Master File Lead

    Mar 2016 - Mar 2021

  • Lead Document Management Associate

    Apr 2014 - Mar 2016
• 

  TransPerfect

  Feb 2023 - now

  Associate Clinical Document Lead