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.