Clinical Project Manager

Hobson Prior are looking for a Clinical Project Manager to join an innovative global organisation where you will be based in Brussels on a contract basis. If you would like more information on this role, please get in touch now!

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• 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
• 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. Such as for Safety Monitoring/Data Monitoring Committees, planned Interim Analyses, and final data reporting for Results Interpretation Meetings and final CSR.
• Ensure that the scope, and all tasks and responsibilities for a study, are appropriately reflected in all study contracts and amendments. Ensure that scope changes are tracked, appropriately endorsed, and reflected in contract amendments before implementation of activities by the CRO/Phase 1 Unit.
• Review and challenge CRO/Phase 1 Unit strategy and plans, if appropriate.
• 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 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.
• 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.
• Understand, manage, track and ensure accuracy of study budgets, including the forecast and accrual information.
• Any other assigned duties.

Key Skills:

• Excellent verbal and written communication in English.
• Proficiency in the Microsoft office suite.
• Good interpersonal skills.
• Excellent time management and organizational skills.

Requirements:

• Educated in a bachelors degree.
• At least three 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 multicentre 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.