Stephanie Maccioni is recruiting for a Principal Data Manager to join a join a small, but growing Data Management Team - not just to deliver data management for this exciting portfolio of studies, but to help shape and influence how a Pharmaceutical Company drives data management excellence for the future. This role can be site or home based with regular visits to their site in Cambridge on a permanent basis.
The Principle Data Manager will be responsible and accountable for the planning, organisation, leadership and coordination of all data management activities on assigned Programs and/or Studies (Phase I to IV) from the database set-up to project closure. You will work closely with Outsourced vendors to ensure quality and timely data management deliverables. Examples of a Program can be all data management activities for a group of Studies across a Therapeutic/Disease area or a group of Studies across multiple phases assigned to single outsourced vendor.
Principal responsibilities will include to:
- Be responsible for performing all tasks in adherence to GCP guidelines and maintain Health & Safety knowledge applicable to the job.
- Oversee all Study related data management activities for outsourced Studies including but not limited to, CRF design, data collection, edit checks & offline listings review, external data reconciliation, Serious Adverse Event reconciliation, medical coding, quality control of database, database locks and archival of data management documents.
- Liaise with the Pharmacovigilance team and Data Management vendor to ensure Serious Adverse Events reconciliation is completed at agreed intervals.
- Liaise with external vendors and Data Management vendor team to facilitate Data Transfer Specifications are created/reviewed/approved and the transfer files are sent at agreed intervals.
- Ensure the in-house data review is scheduled and completed in a timely manner. Also, co-ordinates the data review by clinical, medical and stats teams.
- The Principal Data Manager may also provide supervision to Senior Data Managers ad or Data Managers where they are assigned to their Program of work.
- Bachelor's or Master's Degree in Life Sciences.
- Demonstrate sound knowledge of Drug Development Process and Clinical Data Management processes.
- Extensive experience in Clinical Data Management in the pharmaceutical industry.
- Strong experience working on both paper and EDC (preferably Medidata RAVE) studies.
- Good knowledge of ICH and GCP guidelines.
Full job description available upon request.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
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. Please quote reference 46493 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Stephanie Maccioni
- Phone: 01438 743047
- Reference: 46493
- Posted: 12th September 2019
- Expires: 10th October 2019