ICON Clinical Research India Pvt. Ltd
Position Summary :
To become familiar with Trail Master file documentation and Tmf Operations activities in support of client services contracts and internal Icon business needs in accordance with client requirements and Icon procedures, as applicable.
Job Responsibility :
To competently process study documents in accordance with client and study requirements as per study-specific processes, Icon Sops/wps and regulations, where applicable.
*To complete activities related to document receipt and processing which may include but is not limited to: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.
*To liaise with study teams and other TMF Operations staff in order to fulfil job responsibilities and activities and to assist in providing guidance to study teams for study file archiving activities.
*To maintain study files as per study and/or client requirements or in accordance with Icon Sops/wps and applicable regulations.
*To provide information necessary to complete client and/or departmental status reports as requested by the management of the TMF Operations department.
*To inform the Manager of training issues, project activities, quality issues and timelines as directed.
*To provide copies of study documents to Icon or client personnel as requested.
To participate in client and/or Icon audits as necessary.
*To participate in document archiving activities as necessary.
*To provide inputs for improvement in the process of acquiring the knowledge and skills.
*To maintain document record and filing supplies ensuring adequate supplies are available to TMF Operations staff.
A minimum of 2 years experience in eTMF. Prior relevant document management/related experience.