Lead Clinical Data Manager

Proclinical is advertising a vacancy for a Lead Clinical Data Manager position with a leading clinical research organisation (CRO). The company specialises in researching pharmaceuticals, healthcare, and nutrition, and assists pharmaceutical and biotech companies in developing top prescription drugs in the current marketplace. Based with the company's UK team on a home-based capacity, this position offers an exciting opportunity to work with a company that provides innovative and dynamic solutions.

Job Responsibilities:

• Ensuring that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
• Working 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
• Providing DM project team leadership and accountability; leads data focused internal project team meetings.
• Meeting with the study leads of ECD Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental.
• Proactively identifying potential risks/mitigations, effectively communicating data-driven discussions in order to achieve database lock dates, keeping the Project Manager apprised of project progress.
• Maintaining 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 consulting with Project Manager and/or functional group management as necessary.
• Keeping 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).
• Coordinating 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).
• Provide support to Data Management supervisors and managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills and achievement of competency standards.
• Accountable for learning new DM technologies and applied processes, keeping up-to-date with industry wide technology and feasibility for process improvement.

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
• In lieu of above requirement, approximately eight years of 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.
• Four or more years of Electronic Data Capture experience.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

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 contact Tom Magenis at +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.

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