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Details

Director Clinical Trial Capabilities


Reference:SCAENH-063577 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Director Clinical Trial Capabilities
Our client, a global pharmaceutical organisation are currently recruiting for a Director of the Clinical Trial Capabilities team. As the Director of Clinical Trials Capabilities you will be accountable for clinical trial capabilities within the Clinical Development Organization. You will lead the regional organization that provides the global clinical trial capabilities in support of global clinical development which includes site activation/management/closeout, site contracting, clinical finance, records management, training, and trial metrics across multiple therapeutic areas.

Responsibilities
• Responsible for implementing the staffing strategy for trial capabilities (site activation, site contracting budgeting, payment and reporting, study training management, site maintenance and closeout, etc.) enabling global clinical trial delivery
• Responsible for ensuring the utilization of technology and informatics to standardize and increase efficiency of clinical trial capabilities and resources
• Support global solutions across geographic regions and in conjunction with other clinical development functions
• Ensure activities are executed in a manner consistent with established guidelines, best practices and in compliance with GCP and all applicable regulations
• Ensure flexibility of resources across therapeutic areas to manage changing portfolio staffing needs
• Ensure inspection readiness through a complete, accurate and readily available Trial Master File (TMF) at all times.
• Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within Clinical Development
• Enable a culture of continuous improvement to drive efficiency through process improvement, technology and automation, people skills, and shared learning
• Engage in the external clinical development community to leverage environmental improvements and ensure external learnings are incorporated into continuous improvement efforts
• Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical development
• Effectively manage an agile organization that continuously meets the needs of a changing portfolio
• Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment based decision making in clinical delivery

Requirements
• Bachelor’s degree preferably in a scientific or health related field
• Minimum of 5-7 years of experience in the pharmaceutical industry and/or clinical research experience
• Prior supervisory experience managing a large organisation
• Experience in, and/or leading different groups in drug development
• Knowledgeable of clinical development compliance reporting requirements
• Broad understanding of pharmaceutical drug development process and clinical research
• Prior experience supervising a large organization
• Prior experience managing/negotiating clinical trial budgets/contracts
• Flexibility to adjust quickly and effectively to changing business priorities and needs while dealing with ambiguity
• International or regional clinical development experience
• Proven ability to influence cross functionally without direct authority
• Proven ability to develop diverse organizational talent
• Ability to represent positions on difficult business issues


If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252