Clinical Data Manager/ Clinical Data Project Lead

Recruiter
Planet Pharma Staffing Limited
Location
Cambridgeshire
Posted
24 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Job Responsibilities: Be the data manager data expert for the internal study team and first point of escalation for the vendor. Review and agree high level study timelines with the study team and effect this with the data manager vendor. Review and agree data manager vendor study timelines and processes. Review and approve data manager documents provided by data manager vendor. Conducts peer review of Synopsis, Clinical Study Protocol and SAP Monitor and track data manager vendor activities to ensure they are complete, and KPIs are met i.e. there is a constant data flow (CRF, Lab and PRO, eDiary data entry/ data upload, query process, coding process) Ensure data quality assurance Ensure that quality control checks are occurring by the data manager vendor. Review the findings with the data manager vendor to ensure appropriate level and action has been taken. At the end of each trial, ensure that close out activities have been performed by the data manager vendor, all associated systems and documents are at a data manager support for electronic submission activities as appropriate. Candidate qualifications/ requirements: Successful complete of academic degree in related discipline, or similar formal education and training. Proven experience in performing as the lead data manager from study start up through to study close out for in-house and vendor managed projects. Project management experience. Proven experience in database set up and use of EDC systems for CRF, and useful for ePRO and eDiary. Use of data visualisation/data analytic techniques experience (e.g. Spotfire, Comprehend, CRO tools etc) would be an advantage. Excellent communication skills to build a strong team rapport with cross functional study teams and with DM vendor. Be able to focus into the detail as appropriate but still be able to relate to the bigger picture

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