Clinical Data Management Manager
Ian Marlow at CK Clinical is looking for a Clinical Data Management Manager to join a Global Biotech company on a 12 month contract to be based at their site in the Home Counties.
They will project manage Clinical Data Management (CDM) activities for all studies within a product/therapeutic indication from Protocol review to Database Lock.
The main responsibilities of the Clinical Data Management Manager will include:
- Overseeing a number of lead data managers working on studies within a drug area to successfully meet all deliverables, on time, and to a high standard of quality.
- Ensuring that Clinical Data Management (CDM) procedures and processes are adhered to and meet business requirements.
- Accountability for meeting study/project timelines.
- Leading CDM activities for assigned project teams.
- Communication within their assigned product teams globally and cross-functionally.
- Overseeing a number of lead data managers working on studies within a drug area, ensuring consistency and accuracy of content.
- CDM representation on assigned project teams e.g. Global Clinical Study Team.
- Leading/participating in CDM process improvement forums, as required.
- Project level resource management in conjunction with Senior Manager CDM.
- Leading electronic submission activities.
- Overseeing selection of insourcing/outsourcing partners for assigned studies including: *Input to Request for Proposal (RFP) *Review of insourcing/outsourcing partners' proposals *Participate in insourcing/outsourcing partners' evaluation/audits *Participate in insourcing/outsourcing partners' presentations *Review project scope of work documentation
- Assisting with response to questions and findings from Clinical Quality Assurance (CQA) and other departmental audits
- Participating in development and review of policies, SOPs and associated documents for CDM
- Attending relevant focus group and committee meetings e.g Clinical Data Interchange Standards Consortium (CDISC), Oracle Clinical User Group (OCUG), Association for Clinical Data Management (ACDM/SCDM) etc.
- Maintaining and improving global collaboration within CDM and associated functions.
- Promoting and being an advocate of CDM internally and externally;
As a Clinical Data Management Manager, the following qualifications, skills and experience are required:
- General leadership and management experience;
- Strategic sourcing experience;
- Related experience in CDM;
- Experience working with external suppliers;
- Experience working in an FSP model;
- Use/oversight of EDC systems
For more information or to apply for the Clinical Data Management Manager role, please contact Ian Marlow or Stephanie Maccioni on 01438 743047 or email email@example.com or firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical 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 CL33605 in all correspondence.