Lead Clinical Data Manager
A global pharmaceutical organisation have an exciting job opening for a Lead Clinical Data Manager to be based in the UK on a contract basis. This Lead Clinical Data Manager role will take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Also assume responsibility for all data management activities leading to database lock according to client quality expectations, within project timelines and budgets.
- Lead study Data Manager for studies which are highly complex including but not limited to - combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines.
- As the study data lead/Client programme lead; be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team's output to ensure the highest quality, while adjusting resource allocations accordingly.
- Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
- Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings
- Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training.
- Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Clinical Pharmacology Project Manager to ensure that Sponsor approval is received and the scope change processed.
- Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations.
- Coordinates with the DM Global Trainer and DM technology SMEs to coach and mentor study members on DM technologies and best practices for DM applications/tasks such as (EDC execution, SOP forms completion, tracking tools, reviewing vendor data in SAS Viewer, data listings creation, data cleaning).
Skills and Requirements
- University/college degree (life science, pharmacy or related subject preferred)
- Extensive hands on Lead DM experience with focus on managing large, phase III studies.
- Excellent understanding and experience in the analysis of protocol amendments to assess the impact on a clinical trial, production of technical DM specifications to drive CRF and database change.
- Skilled at advanced planning and management of multiple elements of a phase III trial
- Oversight, leadership and escalation point for supporting DM team, CRF Developers and Database Programmers.
- Working directly with clients, experience in monitoring DM hours vs budget
- Confident in making key study decisions and producing audit ready documentation to support these
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