Study Operations Lead

1 day ago

Dublin, Dublin City, Ireland Novartis Farmacéutica Full time

Job Description

The Study Operations Lead is a critical role that requires a unique blend of clinical expertise, leadership skills, and business acumen. As a member of the clinical operations team, you will work closely with cross-functional teams to plan, execute, and deliver clinical trials.

About the Team

  • You will be part of a dynamic team that is passionate about improving patient outcomes through innovative clinical research.
  • Collaborate with experienced professionals who share your passion for clinical research and development.

Responsibilities

  • Lead clinical trial teams in collaboration with the Clinical Operations Program Head (COPH) to deliver complex global studies.
  • Create effective dynamics within the clinical trial team, ensuring performance, priorities, and communication are met.
  • Guide planning and decision-making at the study level, ensuring assigned clinical studies are delivered according to the Operational Execution Plan (OEP) and clinical study protocol.
  • Foster an agile culture within assigned studies, working to achieve sprint goals and cycles, thereby maximizing collaboration and minimizing dependencies.
  • Oversee study recruitment and implement mitigation strategies as needed.
  • Achieve excellence in study operations and management through process improvement.

Requirements

  • Bachelor's degree in life sciences/healthcare or a clinically relevant field; an advanced degree is preferred.
  • 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.
  • 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.
  • At least 3 years of recent people management experience in a complex matrix environment.
  • Proven abilities in negotiation and conflict resolution, strategic thinking, strong analytical, and problem-solving skills.
  • Experience in developing effective working relationships with internal and external stakeholders.
  • Excellent communication and presentation skills, with the ability to communicate across all levels.

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