Our client, a biopharmaceutical company based in Boston, is seeking a Clinical Trials Project Manager to oversee the execution of Phase II and Phase III clinical studies. This role manages timelines, budgets, and vendor relationships across multiple concurrent trials while ensuring compliance with FDA regulations and Good Clinical Practice standards.
The position works closely with clinical operations, regulatory affairs, biostatistics, and external contract research organizations to keep studies on track. The ideal candidate has direct experience managing trial milestones, site selection, and data quality oversight in a regulated pharmaceutical or biotech environment.
This is a hybrid contract role based in Boston, with on-site presence required for study team meetings, site initiation visits, and sponsor audits. The engagement is expected to run through the end of the study's current phase, with potential for extension based on program needs.
Responsibilities
- Manage day-to-day operations of assigned clinical trials from startup through closeout
- Develop and maintain trial timelines, budgets, and enrollment forecasts
- Serve as primary liaison between sponsor, CRO, and investigative sites
- Monitor site performance and escalate risks to senior leadership
- Review and track regulatory submissions and IRB documentation
- Coordinate cross-functional study team meetings and maintain action logs
- Oversee vendor contracts and ensure deliverables meet quality standards
- Support audit readiness and inspection preparation activities
Requirements
- Bachelor's degree in life sciences, nursing, or related field
- 5 or more years of clinical trial project management experience
- Working knowledge of FDA regulations and ICH-GCP guidelines
- Experience managing CRO and vendor relationships
- Proficiency with clinical trial management systems (CTMS)
- Strong organizational skills with ability to manage multiple studies simultaneously
- Excellent written and verbal communication skills
- PMP or CCRP certification preferred
Benefits
- Competitive hourly contract compensation
- Health insurance options through staffing agency
- Weekly direct deposit payroll
- Opportunity for contract extension or conversion
- Access to Careerscape recruiter support throughout assignment
- Professional development resources
- Paid holidays during contract period
- Referral bonus program