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.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Project Management and Regional Operational Knowledge
· Use project management skills, processes and tools to develop and execute local, regional and/or global clinical trials as described below:
· Scope – Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes (per change control process) as needed to meet the deliverables of the trial.
· Timeline – Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies.
· Risk – 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.
· Budget – Understand the cross-functional, trial-level budget components. Create and monitor the overall budget and assumptions using financial tracking tools. Routinely network with appropriate business partners, on trial-level budget status and changes.
· 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 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 Development, CDDA, 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.
Clinical Trial Process Leadership and Expertise
· 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.
· Demonstrate ability to lead and influence in the midst of ambiguity and coach peers, cross-functional team members and TPOs on aspects of clinical trial process and regional specificities.
· Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools from study implementation through closure.
· Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.
· 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.
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
· Flexibility to adjust to altered priorities
· Clinical trial experience with a strong working knowledge of the clinical research process.
· Proficiency in use of project management tools and techniques (e.g., Critical Chain, MS Project, MS, Excel, MS Powerpoint)
· Ability to travel periodically
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