Clinical Trial Start -Up AssociateMay 24, 2022
Trial Capabilities ManagerMay 27, 2022
Associate Clinical Trial Project Manager – Cork
I’m working alongside an American Pharmaceutical company that’s looking to hire a Associate Clinical Trial Project Manager for their growing team in Cork, Ireland. This is a full-time, permanent position.
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.
- 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 obtaining regional input to provide to the study teams.
- Single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is current and inspection ready at all time.
- 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.
Minimum Qualification Requirements:
- Bachelors or University degree (scientific or health-related field preferred) and 3 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree.
- Minimum of 3 years clinical trial experience with a stong working knowledge of the clinical research process
- Prior clinical trial site-level or affiliate experience
- Proficiency in use of project management tools and techniques (e.g., Critical Chain, ProChain Enterprise, MS Project, MS Excel, MS Powerpoint)
- Need to travel periodically to AST/ ISST and potentially other scientific/ regional meetings