Job Summary
This position oversees conduct of assigned projects, with focus on strategic clients and their clinical trials. Includes interaction with internal team members, clients/sponsors, functional service providers, contractors, and clinical staff.
Essential Duties and Responsibilities
Includes, but not limited to, the following:
- Proactively identifies, analyzes and resolves project issues to ensure that milestones are met and the overall project is completed on time and on budget.
- Participates in the identification, selection and management of functional service providers.
- Leads functional project teams and reports to team and company management on conduct of assigned projects.
- Acts as principal liaison between project/study sponsor(s) and functional service providers, independent consultants and investigative sites.
- Assumes responsibility for assigned project management activities (i.e., maintenance of timelines, analysis, creation and maintenance of customized project management tools, etc.).
- Oversees and tracks project associated budgets for functional service providers and contractors in the delivery of services.
- Maintains close contact with functional service providers, contractors, study investigators and clinical teams to ensure they are in compliance with protocol and overall clinical trial objectives.
- Travels as needed to observe and discuss projects, build positive working relationships and maintain enthusiasm regarding clinical trials.
- Authors and/or reviews all overall study documents including: protocols, ICFs, CRFs, data management plans, table shells, study reports.
- Develops and institutes project metrics to ensure all processes are performed in an efficient, high quality manner. Tracks performance of contractors/functional service providers against project plans, budgets and contract specifications.
- Provides status reports and makes presentations to upper management.
- Oversees study team consisting of CRAs and project support staff.
- Maintains a high level of professional expertise.
- Maintains familiarity with clinical/scientific literature and project management best practices.
Education, Experience and Required Skills
- A bachelor’s degree, or greater, in a natural science or related field and 10 years of related work experience is required.
- Experience working with cross-functional teams, consisting of internal and external personnel.
- Prior experience managing or overseeing clinical trials, including general understanding of all specialized support functions.
- Experience managing budgets is preferred.
- Working understanding of the drug development process.
- Working knowledge of FDA regulations, guidelines and GCPs (including ICH GCP E6 R3).
- Demonstrated exceptional organizational, communication and interpersonal skills.
- Able to travel as needed. (Up to approximately 25%)
- Strong computer skills required. Must be experienced with word processing, spreadsheet and database applications, including MS Office (Word, Excel, PowerPoint, and Project).
Please email your CV to careers@kaizenclinical.com, if you are interested.