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About the role

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  • Recognize, exemplify and adhere to ICON's values which center around excellence in execution, exceeding expectations, and enhancing relationships 
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs Travel (approximately 10%) domestic and/or international 
  • To possess a knowledge of ICH GCP, appropriate regulations, relevant ICON SOPs, ICON internal tracking systems, and Client SOPs / Client systems (when applicable) 
  • To assist the project teams with the set-up, organization and maintenance of clinical study documentation (e.g. Study Files, CRFs, etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archival 
  • To assist in the processing of Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study 
  • To share responsibility in the quality control audits of clinical study documentation (e.g. Study Files, CRF Files, Monitoring Files, etc.) to ensure study files are inspection ready at all times 
  • To facilitate and coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies, and study binders) as appropriate 
  • To assist project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to study/client systems (as appropriate) 
  • To run, review and analyze study reports for accuracy and work with the project teams to ensure updates are completed correctly 
  • To assist in coordination of study related payments, if applicable 
  • To contact and serve as a contact for clinical sites for basic requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.) 
  • To assist in the tracking and distribution of safety reports 
  • To coordinate document translation, if required To assist and attend the Project team with meeting coordination, activities preparation, generation of meeting minutes and agendas 
  • To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations 
  • To assist with the coordination of various tracking reports, including but not limited to, team member tracking and training 
  • To work in collaboration with internal and external colleagues to meet project objectives and timelines 
  • To Keep the Project Manager / Project Director / Clinical Operations Designee informed of any issues within the Project Team which require attention 
  • To maintain client and patient confidentiality Other duties as assigned
List #1

Day in the life

Mission, vision, Values
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Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o

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Deepak shares his experience as Clinical Data Management Project Manager at ICON Strategic Solutions.

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