Study Director

4 weeks ago

Dublin, Dublin City, Ireland Healthcare Businesswomen's Association Full time

Job Description Summary

We are currently seeking a Study Director to join our global team in Dublin, Ireland.

The Study Director is the leader of the cross-functional clinical trial team (CTT), guides planning and management of the assigned clinical study/studies end-to-end to achieve global objectives. Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT. Oversee budget and people allocation within assigned study/studies. The Study Director promotes operational excellence through process improvement and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs. The Study Director is accountable for resolution of study management operational issues and impediments within assigned study/studies.

Key Responsibilities:

  1. Lead the clinical trial team in collaboration with the Clinical Operations Program Head (COPH), ensuring delivery of complex global studies.
  2. Create effective CTT dynamics and achieve performance, priorities, and communication in close collaboration with CTT sub-team leaders.
  3. Guide planning and decision making at the study level, ensuring assigned clinical studies are delivered per the Operational Execution Plan (OEP) and clinical study protocol.
  4. Foster an agile culture within assigned studies, working to achieve sprint goals and cycles, thereby maximizing collaboration and minimizing dependencies.
  5. Oversee study recruitment and responsible for activating mitigation strategies.
  6. Achieve excellence in study operations and management through process improvement.

Essential Requirements:

  1. Bachelor's degree in life sciences/healthcare (or a clinically relevant degree). An advanced degree is preferred.
  2. At least 7 years of recent experience in clinical research or drug development spanning clinical activities in Phases I through IV studies of medium to high complexity.
  3. At least 3-5 years of recent contribution to and accomplishment in all aspects of conducting clinical studies (e.g. planning, executing, reporting and publishing) of medium to high complexity in a global matrix environment within the pharmaceutical industry or a contract research organization.
  4. At least 3 years recent people management in a complex matrix environment. Experience in managing people strongly preferred.
  5. Proven abilities in negotiation and conflict resolution, strategic thinking, strong analytical, and problem-solving skills.
  6. Experience in developing effective working relationships with internal and external stakeholders.
  7. Excellent communication and presentation skills (both oral and written), with the ability to communicate across all levels.

Skills Desired:

Agility, Budget Management, Clinical Monitoring, Clinical Research, Clinical Trials, Lifesciences, Resource Management (Organizational)

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