Associate Director, Data Manager (Interim) in London
Andy Leake is currently working with an exciting start-up company who are looking for a passionate individual. They are a well backed biotechnology company developing next-generation, programmed T cell therapies for the treatment of cancer. They are currently looking for an Associate Director, Data Management to join on an interim basis for 6 months initially.
As an Associate Director, Data Management the successful candidate will manage an outsourced global data management vendor and processes from protocol development through to regulatory submission. This successful candidate will ensure efficient Data Management processes, to ensure quality and timely delivery of Data Management Services.
Key responsibilities will include to:
- Be accountable for the project management, oversight and timely delivery of clinical trial data and documentation to relevant industry data standards and according to agreed timelines, budget and quality requirements.
- Plan and track content, format, quality, and timing of data management deliverables, including, but not limited to, eCRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival; ensures deliverables are on time and within budget.
- Act as the main liaison between the clinical study team, the vendor and other functional partners for all issues related to data for assigned CAR T clinical trials.
- Plan and manage data management aspects of global clinical trials through management and oversight of outsourced data management staff.
- Be responsible for Inspection Readiness of all data management.
- Be responsible for maintaining oversight on outsourcing supplier contracts in line with the role.
- Create and report data management updates to management on a regular basis; report on performance to plan.
- Ensure clean and valid clinical study data for delivery to clinical study teams and subsequent analysis.
- As a functional lead on the clinical study team, ensures timely study start up and database availability.
- The successful candidate should hold a degree in a scientific discipline.
- Proven experience of working with a Pharmaceutical/CRO/Biotechnology organisation, as Clinical Data Manager.
- Experience in vendor oversight.
- Good submissions experience.
- Relevant professional experience in an Oncology clinical trials environment.
- Ideally worked in both CRO and sponsor data management positions.
For more information or to apply for this position, please contact Andy Leake on 01438 842 966 or email email@example.com. Alternatively, please click on the link below to apply online now. 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 45970 in all correspondence.