One of our clients, a global market leading CRO, requires a Clinical Data Lead. The successful candidate can be based in Buckinghamshire or Hampshire, UK, Dublin, IRELAND or Paris, FRANCE.
The lead data management point of contact for day to day activity on a study with key responsibilities for study set-up and close-out tasks, as well as overseeing and coordinating tasks delegated to the study team members, both locally and in other offices, reporting to the Data Management Project Manager.
Record all billable and non-billable time in the appropriate timesheet management system (e.g. PlanviewTM)
Take part in study kick off meetings (internal and external), along with the Data Management Project Manager (DMPM),
Read, ensure understanding and adhere to the study protocol, contract and scope of work for all tasks during set-up, maintenance and close-out of the study,
Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the DMPM and Contract Analyst,
Compile the change order log for review by the DMPM,
Perform revenue recognition and revenue forecasting process on a monthly basis for review by the DMPM,
Lead the development of Electronic Case Review Forms (eCRF), edit checks, data review and oversight listings (DVS),
Lead development of the data management plan and study specific procedures, •Ensure effective implementation of standard metric and status reporting on the study,
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 or client Auditors.
Experience and Qualification
Proven experience in clinical data management or other relevant experience,
Ideally experience of at least one of these 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 skills, •Strong client relationship management skills, and the aptitude to develop this further,
Excellent organisational and planning skills as well as a demonstrated aptitude for project management, and the ability to lead more than one project and prioritise accordingly.