Hobson Prior are currently working with a swiss based biopharmaceutical company who are seeking a Senior Clinical Trial Manager to join them on a permanent basis in Lausanne. This position is responsible for leading, planning, implementing and delivering international clinical trials in Oncology and onco-haematology.

Job Responsibilities:

• Accountable to lead the overall initiation, coordination, implementation and management of international clinical trials from start-up to close out.
• Manage operational and technical aspects of projects including budgeting, study initiation and risk management.
• Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met.
• 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;
• Monitor vendor and CROs performance and ensure continuous oversight.
• 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:

• Strong project management skills.
• Excellent budgeting, planning, and communication skills.
• Ability to lead and influence a cross-functional study team and external partners.
• Strong negotiation skills.
• Strong scientific knowledge and involvement.
• High degree of initiative and ability to work independently.

Requirements:

• University degree or equivalent in Life Sciences.
• Fluent in English - French and another European language are an asset.
• Large scale experience is essential.
• Former experience in contributing to protocols and clinical development plans.
• 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.
• Willingness to travel according to business needs (10-30%).

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.