Senior Clinical Project Manager

An excellent opportunity has arisen for a Senior Clinical Project Manager to join a world-wide biopharma organisation who are focused on changing the lives of patients living with severe diseases. This is position is responsible for the delivery of one or more studies from protocol through to study report and archiving.

Job Responsibilities:

• Accountable to lead one or more multi-functional, Clinical Study Team(s) / Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across the organisation's internal and CRO/Phase 1 Unit teams.
• If a Clinical Pharmacology study, ensure selection of the optimal Phase I Unit within or outside the SPI framework depending on the specialist need of the study.
• At the study kick-off meeting, articulate study scope, goals, and expectations of the organisation to the CRO/Phase 1 Unit and ensure any relevant information that may impact the set-up of the trial is highlighted and accounted for in the trial planning.
• Demonstrate robust oversight of sponsor delegated activities by regularly reviewing CRO/Phase 1 Unit performance through use of KPIs, metrics and deliverables, with a focus on trial subject safety, data quality, and critical activities that might delay the project or impact budget.
• Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless, and timely, access to bioanalytical and/or safety data for review meetings and so allowing prompt decision making.
• Ensure that the scope, and all tasks and responsibilities for a study, are appropriately reflected in all study contracts and amendments.
• Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate.
• Ensure a risk assessment is performed and a Risk Mitigation Plan is set-up at the beginning of the study and maintained by the partner CRO.
• Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) / Joint Clinical Study teams and ensure that the cause, impact, remedial actions & preventative steps are assessed for any issues identified to avoid recurrence. Findings, including mitigation plans, to be discussed with the CRO and communicated to all appropriate internal and external stakeholders.
• Become familiar with the competitive landscape; engage with KOLs, investigational sites, patient advocacy groups and other relevant organizations.
• Any other assigned duties.

Requirements:

• Minimum BA/BSc
• A minimum of 3 years relevant experience in clinical development including team leadership.
• Experience or capability to manage in-house and/or outsourced regional or global Phase 1, 2 or 3 studies (First in Human to multicenter clinical studies) from study start-up to study report completion.
• A SrCPM must have substantial experience in study management in different indications and proven ability to manage complex multinational studies or multiple simultaneous studies from start to end.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.