Clinical Trial Project Manager - Multiple Opportunities
The Clinical Trial Project Manager (CTPM) Associate leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The CTPM Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.
- 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).
- Demonstrate understanding of drug development process. Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise.
- Be knowledgeable of the global and regional operating model; coordinate and facilitate geographic and functional input to provide to the study teams.
- Accountable for ensuring a state of inspection readiness of the TMF records created, maintained, finalized, and owned by Clinical Development
- Network and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown, assess situations, and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver the clinical trial.
- Bachelors or University degree (scientific or health-related field preferred) or an advanced degree.
- Applied knowledge of project management 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
For a confidential discussion and more information on the role, please contact Josh Barnes.