Base pay range
$73.00/hr - $78.00/hr
W2 only - Not available for C2C or 1099 consulting
Time Zone Support
Eastern Time (EST)
Position Summary
This position is responsible for the overall coordination and management of operational activities related to the planning, execution, and completion of a clinical trial. Key responsibilities include overseeing project deliverables, ensuring adherence to budget, and proactively managing risks. The role also involves leading cross-functional project teams and managing participating study centers to ensure timely, on-budget delivery of high-quality outcomes.
General
- Drive planning, development, and execution of timelines, while identifying and tracking the team's critical path
- Execute and control project activities, including scope, schedule, budget, and risk associated with each assigned project and report performance to senior management
- Establish communication plans for information distribution to team members
- Identify and track key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed)
- Integrate understanding of constraints across and within projects and recommend alternatives
- Identify, evaluate, and select external vendors (central lab, central IRB)
Clinical
- Assist the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents
- Develop patient recruitment strategies to ensure goals are achieved
- Oversee development of CRFs and clinical databases
- Develop contracts for and perform ongoing management of vendors to ensure deliverables and performance adhere to contract
- Support academic coordinators
Experience
- 5+ years of relevant experience with project management and clinical trials
- Experience collaborating with academic centers preferred
- Experience in rare disease and pediatrics is a plus
- Experience in small, fast-paced biotech is a plus
- Demonstrated experience coordinating interdepartmental activities to meet protocol and program goals
Education & Training
- Bachelor’s degree or equivalent in the life sciences or related field required
- Additional coursework or certifications in clinical trial planning and operations desired
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Project Management
Benefits
- Medical insurance
- Vision insurance
- 401(k)
- Disability insurance