Clinical Trial Manager

Hobson Prior are looking for a Clinical Trial Manager to join a brilliant biotech organisation on a permanent basis located in Lausanne. Our client is focused on the development of drugs within a number of therapeutic areas.

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

Key Responsibilities:

• For this position, you will be responsible for directing the general instigation, organisation, application and supervision of global clinical trials at different phases throughout mission duration.
• Manage the cross functional study team devoted to the clinical study to guarantee clinical program objectives and timelines are met.
• Handle operational and technical facets of projects involving budgeting, timelines and risk management.
• Expect possible problems and risks within the clinical program, create contingency plans and drive solution implementation.
• Manage and coordinate external vendors, such as Contract Research Organisations (CROs), central laboratories, etc. You may be involved in the selection process, depending on study status.
• 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, if needed, 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.
• Any other assigned duties.

Key Skills:

• You will be customer oriented and have solid team-spirit with the capability to fa collaborative team setting and to function efficiently with others in a fast-paced matrix establishment.
• Proficiently anticipating hindrances and hold-ups and acting as a problem solver with a sense of urgency.
• Solid negotiation skills, scientific knowledge and involvement.

Requirements:

• Educated to a degree level (Bachelor's or Masters') in the life sciences or attained an equivalent qualification.
• Must be able to travel up to a maximum of 20%.
• For this role, you will have demonstrated at least 5-7 years of experience as Global Clinical Trial Manager or similar functioning experience in Pharma (sponsor), involving experience leading global Phase I & II studies from set-up to close-out.
• As Global Clinical Trial Manager, you have operated on numerous disease areas, including rare disease and oncology (this is a must).
• Former experience in directing global clinical studies in Phase III is an asset to the role.
• Past experience in pharmacokinetic studies (e.g. DDI, ADME) is a benefit for the role.
• Prior experience in Management and Filing of Trial Master File (Veeva Vault knowledge is advantageous).
• Previous experience in external audits, would be an asset.
• Earlier experience in adding to protocols and clinical development plans.
• Fluent in English - Fluency in French is also desirable, but not essential to the role.

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.