Job ID: #9788

Clinical Project Manager

Cambridge, MA
Work For Us
Management

Position located in Cambridge, MA

 

Responsibilities of the Clinical Project Manager:

  • Create and review clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.
  • Ensure uniform processes/documentation between projects.
  • Develop and drive execution of operational plans for early research programs that integrate non-clinical, CMC, clinical, regulatory, activities and dependencies.
  • Provide decision making methodologies, identify bottleneck and inconsistencies within interdependencies and facilitate brainstorming with the teams to help identify project issues and resolutions
  • Map out resource and hiring plans for clinical teams in order to meet development needs
  • Manage clinical teams, provide portfolio oversight, monitor progress, and manage resources, timelines, risk, mitigations, budgets, and approve vendor invoices.
  • Manage outsourced clinical operational functions, which may include CRO’s, contracted investigational supply, database management, biostatistics, and other vendors, etc.
  • Negotiate contracts with CRO’s, vendors, sites to adhere to predetermined budgets.
  • Partner with the Chief Medical Officer to oversee ongoing CMC work as needed.

 

 

Requirements of the Clinical Project Manager:

  • BS/BA degree in related discipline and a minimum of 7 years of related experience; or MS/MA degree in related discipline and a minimum of 5 years of related experience; or Equivalent combination of education and experience.
  • Ideally 6-8 years’ experience in a biotech or pharmaceutical research organization; 3-5 years minimal project management experience.
  • CMC experience is preferred.

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    Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering 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.