Srinath R

About Srinath R

A Quality-driven Clinical Researcher having more than 6 + yrs experience in eTMF and Clinical Trial

Experience

1. Sr Technical Document Operations Specialist (Etmf)

   Docs

   Apr 2017 — Present

   Perform system administration activities required to activate/initiate/close out study sites or studies in Phase II to V clinical trials and manage the input of data into specific applications• Perform manual data entry in TMF and various other departmental databases• Ensure consistent receipt, analysis, classification, registration and disposition/filing/retrieval of electronic clinical trial essential documents and other clinical trial related documents to allow for consistent tracking, inspection and security• Coordinate communications regarding progress and completion of study documentation, package creation and data entry activities to the various functional areas as appropriate• Monitor/track appropriate documentation to meet agreed valid SR timelines• Oversee processing of study document requests from cross-functional team members ensuring all urgent requests and inquiries are addressed on time for all studies• Provide QC and audit support• Coordinate, lead and execute special assignments/assistance projects and report with completion metrics• Coordinate, lead and execute SAE,RCAM,Weekly submissions error reconciliation processes and report on completion and error metrics• Coordinate, lead and execute QC process per sponsor QCP, report on quality metrics of team and individuals and communicate with team on error-trend analysis and QC metrics• Monitor/track on the QTS mails–assess and validate the quality/need of query & response turn over from sender, trendanalysis report on monthly basis• Monitor/track on the USTDOS and EDM question mails-assess and validate the quality/need of question & response turn over and share the guidance with team• Monitor/track and report on the reworks/reclassification requests submitted to individuals and global mailboxes

Education

• University of Madras

  Master of Business Administration (MBA), Operations Management

  2014 — 2016

• Madurai Kamaraj University

  Bachelor of Science (BSc), Zoology (Spln. Biotechnology)

  2003 — 2006

• Bharathiar University

  Post Graduate Diploma, Gene Technology

  2007 — 2008

• Bharathiar University

  Master of Science (MSc), Bioinformatics

  2007 — 2009

• AU-KBC and AHERF

  ACC-CTM, Clinical Trial Management

  2010 — 2011