ProClinical is currently seeking a Senior Clinical Project Lead for an opportunity exclusive to ProClinical at a leading global biopharmaceutical company headquartered in Switzerland. This is strategic and operational role, with overall accountability for the management and execution for clinical trials on a global basis within the company's early phase portfolio. The jobholder will have full oversight of study planning and implementation, in addition to program level activities.
- Leading high complexity phase I/II multi-centre / multi-country trials, from an operational and scientific perspective
- Matrix management of multi-disciplinary trial team, to ensure all deliverables are met
- Author of the Clinical Study Protocol, amendments and related documents, Informed Consent Form, Study Operations Manual, monitoring plan etc. Also, accountable for study reports and publications
- Support Med Expert with project specific documentation
- Lead ongoing scientific / medical review of the trial data
- Oversee the work of Clinical Trial Managers and CTAs on a study level
- Taking responsibility for the selection and management of Contract Research Organisations (CROs) and ensuring adherence to scope of work within pre-set guidelines
- Supporting to program-level activities, such as; contributing to project level documentation, coordination and consistency of activities across early phase studies within a project, development of program specific standards, assisting in the coordination of early phase submission documents, and attending and participating in project team meetings, as required
Skills and Requirements:
- In-depth understanding of early phase development
- Extensive background in clinical trial management
- Previous experience with multiple therapy areas
- Strong influencing skills,
- A collaborative nature
- Proven ability to think and work strategically
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 +44 207 4400 638 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.