Clinical Trial Manager
Responsibilities of the Clinical Trial Manager:
- Manages all clinical aspects of study, including: assesses operational feasibility and recommends study execution plans; manages study timelines and metrics; participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel; prepares and presents project debriefings, as required; plans, executes, and attends/manages study-specific meetings (e.g., Study Management Meetings, investigator meetings, etc.) as applicable; participates in site monitoring visits as appropriate.
- Lead the development of the operational plans for clinical deliverables for assigned complex and/or multiple studies in parallel, effectively implementing design excellence in line with the Clinical Development Plan (CDP) and ensuring the principles of Good Clinical Practice (GCP).
- Management of study operational plan and CRO activities, including project timelines, quality of deliverables and follow-up of approved trial budget throughout the life of the clinical development.
- Responsible for the selection and management of CROs and study-related vendors, including defining CRO or vendor responsibilities, negotiating the contract and change orders and establishing a fair and accurate budget.
- Participates in the selection of investigational sites (feasibility), prepares recruitment projections and selection of countries and sites in collaboration with the study team and CRO.
- Oversees medical the development/amendment of clinical study documents, including documents such as study protocols, informed consent forms (ICFs) and the preparation of the regulatory files.
Requirements of the Clinical Trial Manager:
- BS/BA/RN Degree in a life science or a health-related field is preferred, with a minimum of at least 3 years of managing multidisciplinary project teams working on phase I-III global clinical studies Biopharmaceutical/Biotech experience.
- Experience and understanding of global clinical trial operations; preference in the oncology and/or cell therapy space.
- Excellent knowledge of ICH/GCP and regulatory requirements.
- Excellent and transparent communication skills and ability to influence across multiple functions.
- The ability to independently lead several projects simultaneously, an adaptive working style and a creative and thoughtful approach to problem solving.
- Thrives in a fast-paced and evolving environment.
- Must be able to travel up to 10%, domestically and internationally.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.