Senior Clinical Trial Manager

Hobson Prior are recruiting for a Senior Clinical Trial Manager to join a leading pharmaceutical organisation where you will be responsible for leading, planning, implementing and delivering large international Phase III clinical trials in Oncology and onco-haematology.

Job Responsibilities:

• You will lead the overall initiation, coordination, implementation and management of large international Phase III clinical trials from start-up to close out.
• Monitor vendor and CROs performance and ensure continuous oversight.
• Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met.
• Manage operational and technical aspects of projects including budgeting, study initiation and risk management.
• Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation.
• Select, manage and coordinate external vendors, such as Contract Research Organizations, central laboratories, etc.
• Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required.
• Represent clinical operations on multi-function project teams internally and externally; report on study progress.
• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans.
• Ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company's specific SOPs.
• Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents.
• Design, review and approve of all trial related documentation, and establish trial processes.

Key Skills:

• High degree of initiative and ability to work independently.
• Willingness to travel according to business needs (10-30%).
• Strong project management skills.
• Excellent budgeting, planning, and communication skills.

Requirements:

• University degree or equivalent in Life Sciences.
• Fluent in English - French and another European language are an asset.
• Large scale experience is critical.
• Proven track record of successful management of large complex Phase III international clinical trials in the Pharmaceutical Industry or CRO. Previous monitoring experience preferred.
• Deep knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.
• Experience in management of CROs, vendors and consultants.
• Experience in external audits, an asset.
• Oncology experience is desirable.
• Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency.
• Strong scientific knowledge and involvement.
• Former experience in contributing to protocols and clinical development plans.

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.