Ref #: 33298

Employment type: Fixed term - Full-Time

Location: Chennai

Posted: 26-Oct-2021



Records Management Specialist (RMS) is to perform all duties related to the timely processing of essential and non-essential clinical trial documents to facilitate study startup, drug shipment, eTMF maintenance and support eTMF inspection readiness activities.

Key Responsibilities :

Perform system administration activities required to activate/initiate/closeout study sites
or studies in Phase II to V clinical trials and manage the input of data into specific
• Perform manual data entry in: CTMS, TMF, CRF Imaging and various departmental
• Ensure consistent receipt, analysis, classification, registration and
disposition/filing/retrieval of hardcopy and electronic clinical trial essential documents
and other clinical trial related documents to allow for their consistent tracking, inspection
and security
• Screen and sort incoming paper and electronic mail. Date and time stamp cover sheet of
incoming documents. Determine appropriate routing. Prepare outgoing mail and
• Coordinate communications regarding progress and completion of study documentation,
package creation and data entry activities to the various functional areas as appropriate
• Configure/ Create/ Monitor / Update Regulatory Packages
• Maintain weekly document processing metrics/errors/returns/delays for department -
excel spreadsheet.

Required experience and qualifications:

Job Title : Technical Documentation Operation Specialist (TDOS)
Job location : Chennai (Office based)
No of years of experience: 2+ years of exp in documentation
Education Qualification: Any life science graduation
Salary : As per Industry standards with attractive benefits

Why join the DOCS team at ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.

At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.