Senior Clinical Data Manager
- Experience Level
- Experienced (non-manager)
Geoff King at RBW Consulting is working with an incredibly exciting Biopharmaceutical company in the recruitment of a Senior Lead Data Manager as they embark on an unprecedented period of growth in genetic and cell therapies for a variety of serious diseases.
Reporting to the Associate Director of Global Data Management you will perform mid-level data management tasks under minimal guidance, and play a key role on multiple, moderately sized studies. Managing deliverables/performance of external vendors on assigned studies.
Main duties & responsibilities:
- Develops, or plans and oversees development of, edit check specifications, CRF completion guidelines or data entry guidelines, data management plans, data review guidelines, SAE reconciliation plans, cross- functional data review plans, with input from cross-functional study team
- Plans and oversees execution of user acceptance testing (UAT)
- Defines electronic data transfer (EDT) specifications and independently manage external data providers
- Ensures study compliance with SOPs and regulations and develops study-specific training for internal and external study team
- Reviews clinical study protocols and provides input on data management issues
- Reviews and provides input on vendor RFIs, RFPs, proposals, and contracts
- Prepares and delivers presentations at internal and external meetings
- Leads activities of a team on multiple studies, including internal staff and vendors
- Evaluates and mitigates risks to timelines and quality
- Provides input regarding project resource requirements
- Responsible for all aspects of the study deliverables
- May mentor other clinical data management staff
- Bachelor's Degree in a scientific or health field
- Requires many years of relevant work experience in the Biotech or Pharmaceutical Industry or the equivalent combination of education and experience
- Skilled in EDC-related tools and processes
To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on +44 (0) 1293 584 300 and send your CV through to email@example.com or use the apply button on this page.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.