Senior Clinical Data Manager
ProClinical is excited to announce a new Senior Clinical Data Manager role for one of the most innovative CROs in the global market. The role based in East England will look to support phase 1 studies through to marketed products.
- Perform Lead Data Manager role with responsibility for the functional leadership of all Data Management activities on assigned studies from start-up to close out.
- Perform DM start-up activities including protocol review, eCRF design/DB build, definition of data validation strategy, DM documentation, UAT, site training.
- Responsible for the quality of the Clinical Database structure and the clinical data. Perform ongoing data review, coding, SAE reconciliation, manage external data integrations/reconciliations.
- Handle the timelines, deliverables and budgets for your studies.
- Lead or participate in, the development, review and implementation of processes, policies, SOP's and associated documents affecting DM.
- Actively participate in the preparation of project proposals and take part in Business Development presentations to sponsors as required.
Skills and Requirements
- Bachelors degree in a life science field (or equivalent)
- Extensive current experience, preferably in a CRO environment
- Experience leading phase 1-3 studies, complex trial design/oncology
- IBM Clinical Development and/or Medidata RAVE experience
- Experience in performing study start up activities
- Experience with data analytics and/or visualization tools
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Heidi Hennigan on 0203 854 1033 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.