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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Trials Operations Manager


Reference:SCAACF-557277 Location: Cork
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Trials Operations Manager
Our client a global pharmaceutical organisation are currently recruiting for a Clinical Trials Operations Manager to join their team on a permanent basis. As Clinical Trials Operations Manager you will lead and manage the daily operation of the clinical trial capabilities team in support of clinical development.Experience in people management is essential for this role.


Responsibilities

  • Accountable for meeting and exceeding goals for clinical trial operations for development programs
  • Accountable for ensuring site initiation and maintenance activities with the focus on contracts and budgets that 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 team delivering contracts and budgets during site initiation, maintenance, and close out representing progress to business partners
  • Accountable for daily prioritisation of work to meet business needs
  • Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements
  • Develop and streamline processes ensuring efficiency and improved productivity as well as meeting customer requirements
  • Ensure inspection readiness through a complete, accurate and readily available Trial Master File
  • Identify and ensure shared learning across the clinical capabilities organization and with other functional groups
  • Build capabilities in the function through the development and improvement of processes, tools and training
  • 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 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, two years clinical research experience or relevant experience preferred
  • 2-3 years people management experience is essential
  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation
  • 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
  • Fluency in Spanish is desirable but not essential