Clinical Data Lead (Remote)
About the role
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- Lead the development of the specifications, implementation, testing for the Electronic Case Report Form (eCRF) or paper CRF and edit checks (DVS), data review, oversight listings, data management plan, study specific procedures and specifications for custom reporting on the study
- Perform project planning tasks and support the DMPM in the development of the project plan and timelines
- Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory and/or ICON Auditors
- Key point of contact for the sponsor and the study team on day to day study data issues, eCRF design, edit checks, and other implemented components. Organize and lead regular data management team meetings, both internal and with the sponsor
- Review all activities on an on-going basis to identify out of scope tasks and bring to the attention of the DMPM and Contract Analyst and compile the change order log for review by the DMPM
- Develop an understanding of the revenue recognition and revenue forecasting process; perform revenue recognition and revenue forecasting process on a monthly basis for review by the DMPM
- Bachelor’s degree or local equivalent in a scientific discipline and/or appropriate experience
- A minimum of 5 years clinical data management or other relevant experience
- Experience in at least one of the ICON preferred CDMS (Rave, Inform, Oracle Clinical, OCRDC)
- Highly computer literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project)
- Excellent communication and interpersonal skills, both verbal and written
- Strong client relationship management skills, and the aptitude to develop this further
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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