Senior Clinical Project Leader (Early Phase Development)
A new opportunity, exclusive to ProClinical, has arisen within the early phase development division of one of our key strategic clients, a leading global biopharmaceutical company headquartered in Boston. Our client is searching for a Senior Clinical Project Leader. This is both a strategic and operational role, with overall accountability for the management and execution for early phase trials on a global basis. The jobholder will have full oversight of study planning and implementation, in addition to program level activities. Job Responsibilities: 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 For this position, our client is looking for ambitious individuals with an in-depth understanding of early phase development, an extensive background in clinical trial management, significant experience within the field of immunology, strong influencing skills, a collaborative nature, and a proven ability to think and work strategically. Office based in Boston, the opportunity offers enviable exposure to one of the business' most dynamic business units, in addition to providing access to an excellent career development structure and an attractive remuneration package. To Apply: 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 [Phone number removed] or upload your resume on our website - [URL removed] 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.