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Consultant Trial Capabilities

Reference:A006838
Location: Cork
Qualification:Degree
Experience:4-5 Years
Job Type:Permanent
Salary:Not Disclosed
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Consultant Trial Capabilities
As Consultant you will provide leadership, direction and technical support to the Clinical Trial Capabilities Teams focusing on driving efficiency across the regional hub to achieve goals and objectives. This includes owning the regional processes and strategies aligned with other functions, representing trial capabilities globally, and driving continuous improvement. The consultant will ensure inspection readiness at all times through a complete, accurate and readily available Trial Master File.

Responsibilities
• Own the process map and build capabilities through the development and improvement of processes, tools and training and partnering with Clinical System and Supplies Planning to leverage technology to increase efficiency of clinical trial resources
• Identify and Lead shared learning across the clinical capabilities organization and with other functional groups
• Lead and influence a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning
• Partner and influence other functions/leadership to drive efficient clinical development processes and procedures
• Mentor others to deliver on strategies
• SME for global and regional clinical trial processes, driving adoption of best practice
• Therapeutic area leadership through owning TC strategy to execute on clinical trial plans
• Influence global trial strategy to drive regional improved site activation cycle times
• Accountable for meeting and exceeding goals for clinical trial initiation for development programs
• Accountable for ensuring site initiation and maintenance activities comply with local/regional requirements, data privacy requirements and quality standards
• Manage communications/relationships and serve as the point of contact for the trial capabilities deliverable during site initiation, maintenance, and close out representing progress to business partners
• Accountable for prioritisation of work to meet portfolio needs
• Ensure flexibility of resources across trial capabilities teams and geographies
• Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements and external environment
• Develop and deliver strategies to improve customer experience
• Monitor execution of strategy and performance of global processes by local and/ or regional teams via metrics and controls
• Ensure inspection readiness through a complete, accurate and readily available Trial Master File
• Act as system/process owner for any relevant technologies/regional processes and represent the region in global initiatives
• Manage relationship(s) and influence processes with any relevant global third-party technology or services and CROs

Requirements
• Bachelor’s degree preferably in a scientific or health related field, five years clinical research experience or relevant experience preferred
• Understanding of the overall clinical development paradigm and the importance of efficient site initiation
• Experience working with regional or global mind-set
• Strong leadership skills and ability to influence others and lead across the business
• Project management processes and skills
• Appreciation of / experience in compliance-driven environment
• Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
• Effective communication, negotiation, and problem-solving skills
• Self-management and organizational skills
• Effective problem-solving, business acumen and analytical skills to evaluate and resolve complex operational and / or technical issues
• Language capabilities an advantage


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

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




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