Description
Project manage Clinical Data Management (CDM) activities for all studies within a product/therapeutic indication from Protocol review to Database LockResponsibilities include:
- Oversee 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.
- Ensure that Clinical Data Management (CDM) procedures and processes are adhered to and meet business requirements.
- Accountability for meeting study/project timelines.
- Lead CDM activities for assigned project teams.
- Communication within their assigned product teams globally and cross-functionally.
- Review of all study related documents within a project area, ensuring consistency and accuracy of content.
- CDM representation on assigned project teams e.g. Global Clinical Study Team.
- Lead/participate in CDM process improvement forums, as required.
- Project level resource management in conjunction with Senior Manager CDM.
- Lead electronic submission activities.
Oversee 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
- Assist with response to questions and findings from Clinical Quality Assurance (CQA) and other departmental audits
- Participate in development and review of policies, SOPs and associated documents for CDM
- Attend 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.
- Maintain and improve global collaboration within CDM and associated functions.
- Promote and be an advocate of CDM internally and externally;
Skills: 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
If you would like more information on this role please contact Halima Khanom on and email an updated CV
To find out more about Real please visit www.realstaffing.com