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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Manager Clinical Trials


Reference:SCAHII-066481 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Trials Advisor

Senior Manager Clinical Trials
Our client, a global pharma organisation are currently recruiting for a Senior Manager to lead their Clinical Trial North America Maintenance team.In this role you be responsible for site maintenance/close-out, site contracts amendments, records management, training, and trial metrics across all therapeutic areas. You will serve as point of contact for Competent Authority, assist in budget and contract negotiation if needed. Additional local responsibilities may be required as needed/appropriate for the local geography, and/or to cover regional differences.

Responsibilities

  • Accountable for ensuring site 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 representing progress to business partners internally and externally
  • Support global solutions across geographic regions and in conjunction with other clinical development functions
  • Accountable for prioritisation of work to meet portfolio needs
  • Ensure flexibility of resources across North America Maintenance Team
  • Provide expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements
  • Develop and manage strategies to improve customer experience
  • Ensure inspection readiness through a complete, accurate and readily available Trial Master File
  • Identify and ensure shared learning across the North America Maintenance Team organization and with other functional groups
  • Build capabilities in the function through the development and improvement of processes, tools and training and partnering with Clinical Information and Process Automation to leverage technology to increase efficiency of North America Maintenance Team and resources
  • Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning
  • Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable across the North America Maintenance Team
  • 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, five years clinical research experience or relevant experience preferred
  • Understanding of the overall clinical development paradigm and the importance of efficient site maintenance
  • Previous supervisory experience appreciated
  • 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
For more information contact Sinéad Cullen on +353879500821 or [email protected]