Clinical Project Manager

1 month ago

London, Greater London, United Kingdom newscientist - Jobboard Full time
Job Summary

We are seeking a highly skilled Clinical Project Manager to lead our global clinical trials team. As a key member of our clinical operations team, you will be responsible for ensuring the successful delivery of clinical site monitoring on our clinical trials.

Key Responsibilities:

  • Provide operational expertise and leadership to ensure the effective and efficient delivery of clinical site monitoring on our clinical trials.
  • Assess clinical trial site performance, adequacy of monitoring activities, reviews monitoring visit reports and metrics, and proactively identifies and communicates site management and monitoring issues and risks to the Clinical Operations Study Lead and Clinical Monitoring management team.
  • Develops or contributes to the Clinical Monitoring Plan, monitoring tools, visit report annotations, and CRA training materials.
  • Responsible for training the CRAs on the study and ensuring study training compliance is maintained.
  • Reviews monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed.
  • Responsible for reviewing clinical data (e.g. electronic case report forms, central laboratory data, risk based monitoring outputs, etc.) to ensure the CRAs are informed and managing their site's data with quality and integrity.
  • Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times.
  • Conducts regular meetings with their CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency.
  • Conducts co-monitoring visits or other monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs.
  • Works with the Clinical Monitoring management team on developing and updating best practices and processes, with input on discussions around quality by design and operational delivery.

Requirements:

  • Bachelors or equivalent degree required, preferably in life sciences, medicine or related discipline.
  • Minimum of 5 years Clinical Research experience, with at least 3 years of experience in clinical site monitoring.

What We Offer:

We offer a competitive salary and a range of benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a global Employee Assistance Programme.

We are committed to providing an inclusive and accessible environment for all candidates and employees. We welcome applications from diverse candidates and are an equal opportunities employer.

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