Clinical Project Manager

Hobson Prior are currently looking for a Clinical Project Manager for an exciting position based in Switzerland. Our client is a clinical stage biopharmaceutical company focused on advancing modern medicine and improving the management of serious disease. In this role you will be responsible for operational planning and management of clinical trials.

Job Responsibilities:

• Lead the clinical study team and manage trial budget.
• Manage the interfaces and definition of operational specifications for MPAG vs clinical research vendors.
• Develop clinical outsourcing specifications to facilitate bid templates and selection of clinical research vendors.
• Guide the development of standard processes, planning and resource management tools and performance metrics to achieve excellence in clinical program management.
• Involvement with the development of clinical sections of regulatory documents, such as IBs/briefing books/safety updates/CTA/BLA submission documents and responses to Health Authority questions.
• Development of relevant sections of clinical study protocols and related documents in collaboration with CROs; development of study tools, guidelines, and training materials, management of clinical study material, and implementation of issue resolution plans.
• Ensure administrative/operational monitoring of clinical studies.
• Daily interaction with the CRO, third party vendors and study sites to ensure sponsor’s oversight responsibilities.
• Ensure all trial deliverables are met according to timelines, budget, operational procedures and quality/GCP standards.
• Making sure maintenance of Trial Master File in strict compliance with ICH/GCP and internal SOPs.

Requirements:

• Degree or equivalent education within life science/healthcare.
• Minimum of 5 years of experience in clinical trial execution in a biotech or pharmaceutical company or contract research organization.
• Knowledge of the international aspects of drug development process, including knowledge of international standards (GCP/ICH), health authorities (FDA, EMA), local/National Health Authority regulations
• Demonstrated track record of managing a clinical trial from setup to clinical study report (including setup of eCRF, IVRS/IWRS, laboratory related tasks, etc.)
• CRO and site management capabilities with demonstrated ability to solve problems and mediate potential compliance issues
• Proficiency in English, German is desirable.

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.