Lead Clinical Data Manager

A global contract research organisation have an exciting job opening for a Lead Clinical Data Manager to be based in Leeds on a contract basis. The company specialises in research into pharmaceuticals, healthcare and nutrition and offer flexible conditions and excellent career development opportunities. 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.

Job Responsibilities:

• 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
• Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of ECD Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager apprised of project progress.
• Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on Data Management resources or deliverables and consult with Project Manager and/or functional group management as necessary.
• Keep Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. budget status, work scope changes, timeline impacts).
• Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion.
• 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), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• Knowledge of drug development process
• Knowledge of effective clinical data management practices
• Fluent in English, both written and verbal
• In lieu of above requirement, approximately eight years experience in related field (e.g. pharmaceutical, laboratory, data analysis)
• Eight years of combined early or late stage DM experience with four years of direct sponsor management and at least 2 years technical mentoring experience. Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets.
• Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
• Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions.
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Magenis on + 44 203 854 1050 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.