Our client, a dynamic bio-pharmaceutical company headquartered in Switzerland and covering multiple therapeutic areas, is looking for a Senior Clinical Trial Manager for a permanent role based in the French Speaking area of Switzerland.
As a Senior Clinical Trial Manager (CTM) you will be responsible and accountable for leading, planning, implementing and delivering international clinical trials in Oncology and/or Bacterial Infections, to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.
Senior Clinical Trial Manager (896846)
Lead the overall initiation, coordination, implementation and management of international clinical trials from start-up to close out;
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 (CROs), 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.
Qualifications and Experience:
Relevant working/residency permit or Swiss/EU-Citizenship required;
University degree or equivalent in Life Sciences;
Mininum 8-10 years of experience as a global Clinical Trial Project Manager in the Pharmaceutical Industry;
Oncology and/or Infectious disease experience is strongly desirable;
Strong project management skills;
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 contributing to protocols and clinical development plans;
Experience in external audits;
Excellent budgeting, planning, and communication skills;
Ability to lead and influence a cross-functional study team and external partners, strong negotiation skills;
Willingness to travel according to business needs (10-30%);
Fluency in English is required, French is an asset.