GCSO Clinical Project Manager

Hobson Prior currently have an opportunity for a GCSO Clinical Project Manager to join a leading biopharmaceutical company on a contract basis in Slough.

Job Responsibilities:

• Responsible to lead one or more multi-functional, Clinical Study Teams / Joint Clinical Study teams, tailoring the communication interface to ensure effective co-ordination and communication within and across the 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.
• Articulate study scope, goals and expectations of the organisation to the CRO/Phase 1 Unit at kick-off and ensure they are informed about any relevant sponsor information that may impact the management of the trial throughout the conduct of the trial.
• Creates or contributes to detailed planning of the study, timelines, define critical path to enable seamless access to data, early read out of bioanalytical and safety data to enable data review meetings and early decision making.
• Ensure that the scope, 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.
• Supervise study conduct by regularly reviewing CRO/Phase 1 Unit performance through the review of KPIs, metrics and deliverables, with a focus on critical activities that might delay the project, jeopardize quality, and/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.
• Familiarize 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.
• You will work closely with the Program Delivery Lead, other team members and stakeholders as required and serve as the internal key contact for their assigned studies.

Key Skills:

• Motivation, mentoring and integration of individuals on multi-functional international teams.
• Excellent verbal and written communication in English.
• Proficiency in the Microsoft office suite.
• Good interpersonal skills.
• Excellent time management and organizational skills.
• Negotiation skills.

Requirements:

• Bachelor's Degree Required.
• 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.
• Clinical trial management in Early and Late Phase and team leadership.
• Delivery of scientific/medical presentations and training to both large and small audiences.
• Scientific and technical knowledge:

- GCP and regulatory environment
- Medical knowledge and research expertise
- Basic principles of data management and statistics

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.