Senior Global Clinical Trial Manager Early Stages (F/M)

Our client  is a biopharmaceutical company, based in Switzerland. The company develops innovative therapies in oncology and infectious diseases that target high unmet medical needs.
To support the Clinical Operations Department, we are looking for a:

Senior Global Clinical Trial Manager Early Stages (F/M)

Mission:
As Senior Global Clinical Trial Manager Phase I & II, you will contribute to delivering new medicine to the market through planning, leading and delivering international Phase I & II clinical trial. You will ensure that the assigned to your studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice. You will report to the Manager Clinical Operations.
 
Main responsibilities:

• Lead the overall initiation, coordination, implementation and management of international clinical trials at different stages during mission duration,
• 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, timelines and risk management,
• Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation,
• Manage and coordinate external vendors, such as Contract Research Organizations (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,
• 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.

 
Profile required:

• Bachelor or Master degree or equivalent in Life Sciences,
• Proven track record of 5-7 years of experience as Global Clinical Trial Manager including experience leading global Phase I & II studies from set-up to close-out,
• As Global Clinical Trial Manager, you have worked on various disease areas, including rare disease and oncology (a must),
• Experience in Management and Filing of Trial Master File (Veeva Vault knowledge is a plus),
• Customer oriented and strong team-spirit with the ability to foster a collaborative team environment and to work effectively with others in a fast-paced matrix organization,
• Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency,
• Fluent in English.

 
You have the opportunity to join a successful company in which innovation, people and entrepreneurship are the fundamentals of its success.

If you are interested in this opportunity please send your application to Morgan Philips Executive Search Switzerland. Your application will be treated with confidentiality by Anne-Sophie Nicolaï.