Clinical Project Manager
3 weeks ago
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Clinical Project ManagerOur client, a global pharmaceutical organisation based in Cork, is currently recruiting for a Clinical Project Manager to join their experienced and talented clinical development team on a permanent basis. As a Clinical Project Manager, you will lead the cross-functional study team in the development and execution of clinical trials and will be responsible both regionally and globally to deliver trials with quality, on time, and within scope and budget. This role offers hybrid working.
Responsibilities- Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials.
- Partner with other organizations to coordinate and actively participate in affiliate, site, and investigator training.
- 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 enrolment 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 Development, CDDA, and Third Party Organization (TPOs).
- Apply problem-solving skills to daily issues with cross-functional study team (including vendors, affiliates/regions, global team members, and other business partners).
- Identify and assist in developing continuous improvement activities based on industry, regulatory, and technological trends.
- Manage TPO qualification process, selection, and oversight.
- Ensure a state of inspection readiness of the TMF records created, maintained, finalized, and owned by Clinical Development.
- Apply expertise and knowledge of global/regional regulations & Good Clinical Practice (GCP).
- Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies, and draft responses to questions from regulatory agencies, TPOs, and affiliates.
- Combine scientific, regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility, and implementation.
- Utilize clinical development knowledge, problem solving, and critical thinking skills to support the scientific needs of the business.
- Bachelor's or university degree (scientific or health-related field preferred) or an advanced degree.
- Clinical trial experience with a strong working knowledge of the clinical research process.
- Applied knowledge of clinical project management methodology, processes, and tools.
- Demonstrated ability to work cross-culturally with global colleagues and TPOs.
- Strong leadership and networking skills.
- Effective and influential communication, self-management, and organizational skills.
- Proficiency in project management tools and techniques (e.g., Critical Chain, MS Project, MS Excel, MS PowerPoint).
- Ability to travel periodically.
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