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Job #02759

About our client Our client is a leading medical device company, which is focused on the development and commercialization of less invasive medical devices and procedures. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Clinical Project Manager Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage several (possibly global) clinical trials 2) Ensure that the trial is ‘audit ready’ at all times (Project Team training records, central files, system validation, etc.) 3) Manage resources, expertise and knowledge across multiple projects to ensure attainment of project deliverables 4) Communicate (effectively) within the Clinical Project Team and with functional management 5) Provide regular updates regarding the status and progress of trials (Therapeutic Lead, Business Alliance, etc.) 6) Manage project(s) within approved budgets and timelines 7) Compose clinical project deliverables (protocols, final study report, study manuals, study tools, etc.) within CPP framework 8) Prepare investigational site lists and participate in reviewing and approving investigational sites 9) Direct forecasting of devices necessary for the project in collaboration with supply-chain 10) Review and approve various support system specifications (e.g. IVRS, etc.) 11) Coordinate and attend investigator and coordinator meetings, representing the Clinical Project Team 12) Oversee individual clinical trials to ensure that safety concerns and/or adverse events are identified 13) Ensure appropriate responses to safety concerns and adverse events are developed as well as executed 14) Identify project risks, development and implementation of the mitigations for these risks 15) Prepare and present status of the clinical project(s) to the Clinical Management Board 16) Represent Clinical Project Team on PDP core (with or without a clinical trial) 17) Provide updates to the PDP core teams about product risk documents (CRBA, FMEA, etc.) 18) Prepare corrective action plans at individual sites and across trials 19) Participate in internal/external trial-related audits 20) Train others in the appropriate application of clinical research conduct, laws, regulations, standards and compliance with applicable company SOPs and policies Requirements 1) Bachelor's degree in Science/health-related field (Biology, Nursing or Veterinary Sciences preferred) 2) 5 – 7 years of experience in clinical/scientific research, nursing or medical device/pharmaceutical clinical trials (medical devices preferred) 3) 1 – 3 years of experience in managing projects 4) Experience in working with clinical professionals within a team and in a cross-functional product-development setting 5) In-depth knowledge of laws, regulations, standards and guidance governing the conduct of clinical research/studies 6) Ability to understand strategic goals and match business needs of the company 7) Ability to independently lead, manage and provide significant tactical guidance to the Clinical Team 8) Ability to manage complex, multiple and international projects 9) Ability to work independently and in a team environment 10) Excellent presentation and communication (verbal and written) skills