An excellent multinational healthcare company is seeking a skilled International Clinical Trial Manager, you will be based in the desirable area of Basel. This is a chance to join a top healthcare organisation who provide an innovative range of diagnostic solutions and medicines. The ICTM provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Start-up, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations. This is a global role, based at company HQ in Basel, which sits within the Clinical Operations Team and reports to the International Clinical Program Leader (ICPL).
- Provides direction and leadership to one or more clinical operations teams
- Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets and timelines, site selection, quality plans, and clinical supplies management
- Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external providers and collaborative partners.
- In collaboration with functional management, coaches, supports, and provides study specific direction to Study Management team members.
- Provides clinical operations expertise to ensure operational feasibility and delivery
- Oversees forecasting of clinical/non-clinical supplies
- Delivers the operational elements of the study plan
- Provides the day-to-day operational management of CROs and vendors to ensure delivery against
- contracted scope of work
- Identifies areas of best practice and process improvements
- Ensures study adherence to ICH/GCP and SOPs
Skills and Requirements:
- Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans
- Good knowledge of ICH GCP
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call James Mackinnon on +41 (0) 615 881 152 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.