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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