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location: Lexington, Massachusetts
job type: Contract
salary: $68.55 - 80.65 per hour
work hours: 9 to 5
Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.
- Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and company SOPs), on schedule and on budget.
- Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet the company's obligations described in ICH-GCP and the company's business objectives.
- The assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned.
- 6+ years' experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management.
- Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs.
- Experience in more than one therapeutic area is advantageous.
skills: SOP, GCP (Good Clinical Practice), ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.