To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02937

About our client Our client is the biotech division of a global publicly traded pharmaceutical company with over 100,000 employees. They are at the forefront in the development and commercialization of therapeutics in multiple indications, and are well known for high-quality standards and commitment to innovation. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Project Manager Boston, Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Work with Study Team members and other functions, including CROs, QA, RA, etc., to define study deliverables, negotiate study timelines and resource quality targets 2) Develop, update and adjust study timelines as well as resource and quality targets (as appropriate) 3) Work within timeline, budget and quality parameters dictated by the Clinical Development Plan, SOPs as well as other company policies and procedures 4) Communicate study timelines as well as resource and quality targets to team members, external partners and management 5) Work with appropriate team members to select external providers and vendors (e.g. CRO, EDC service providers, labs, third-party image reviewers, couriers, etc.) 6) Serve as the primary clinical contact in contract negotiation and finalization with external partners 7) Work with Study Team members, external providers and other functions to define the scope, duties, deliverables, tasks and processes for all outsourced activities 8) Produce, administer and present the study budget 9) Facilitate execution of clinical study as per time, resource and quality targets 10) Create a regular plan to review the study's progress vs. time, resource and quality targets as well as external provider contracts by reviewing or spot-checking deliverables and metrics 11) Delegate review tasks and compilation of metrics to Study Team members, including Assistant Study Manager (as appropriate) 12) Work with Study Team members and external providers to correct deficiencies discovered as a result of deliverable/metrics reviews (as needed) 13) Identify performance issues and work with the Study Team, external providers and/or Clinical Director to resolve them 14) Train/coordinate training for CRO and other Study Team personnel, including the Clinical Lead and CRAs (external) as well as internal Assistant Study Manager and Biostatistics/Data Management (as appropriate) 15) Supervise activities of Assistant Study Manager 16) Report study status on a regular basis as defined by the Clinical Project Director 17) Work with extended team members to provide clinical inputs for the compound/indication (as required) 18) Participate in ‘lessons learned’ reviews with Study Team members and other Study Managers in other compounds/indications 19) Work with Regulatory Affairs to provide clinical input into regulatory submissions 20) Participate in process development and improvement initiatives with the Director of Clinical Research and other departments 21) Work with QA to develop and execute audit plan 22) Participate in SOP development 23) Provide inputs to develop SOPs and working guidelines Requirements 1) Degree or training in Medicine or Natural Sciences 2) 5 – 7 years of professional experience in clinical research positions of increasing responsibility 3) Background in renal, autoimmune or post-transplant immunosuppressive trials 4) Experience in clinical monitoring 5) Experience in clinical project management (Phase I – III preferred) 6) Good knowledge of medical and biological issues 7) Understanding of EDC and other clinical applications 8) In-depth knowledge of GCP 9) Proficient in MS Word, Excel, MS Project and PowerPoint 10) Superb negotiation and communication skills 11) Ability to plan and organize work as well as follow through on commitments 12) Ability to prioritize and work independently 13) Flexible and self-motivated team player 14) Quality-oriented with social competence and a sense of responsibility