Clinical Operations Manager

1 day ago

Cork, Cork, Ireland beBeeClinical Full time

Clinical Operations Manager - Trial Lead

This role is responsible for leading the cross-functional study team in the development and execution of clinical trials.

Responsibilities:
  • Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies.
  • Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan.
  • Understand the cross-functional, trial-level budget components. Create and monitor the grants and non-grants, and assumptions using financial tracking tools.
  • Partner with other organizations to coordinate and deliver Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs)/Investigator Engagement Meetings.
  • Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including issue management, contingency planning and issue resolution.
  • Be accountable for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET)
  • Manage relationships and serve as a single point of contact and central owner for trial communication, to and from the Clinical Design and Delivery organization, all cross functional team members, and Third Party Organization (TPOs).
  • Apply problem-solving skills to daily issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners).
  • Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
  • Manage TPO qualification process, selection, and oversight.
Requirements:
  • Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant clinical trial experience in a scientific or health-related field; or an advanced degree.
  • Applied knowledge of trial execution methodology, processes, and tools
  • Demonstrated ability to work cross-culturally with global colleagues and with TPOs
  • Ability to influence without authority
  • Strong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projects
  • Effective and influential communication, self-management, and organizational skills
  • Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity
  • Flexibility to adjust to altered priorities
Benefits:

We offer a range of benefits to support your career and well-being, including flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.

Additional Information:

This is a Fixed Term Contract Position. We have 12 and 18 month Contracts available.

Need to travel periodically to AST/ ISST/Investigator Engagement meetings and potentially other scientific or regional symposiums

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