BioPhase · 2 weeks ago
Clinical Operations Consultant
San Francisco Bay Area
Full-time
Hybrid
Senior Level
5+ years expBioPhase is a company focused on clinical operations, and they are seeking a Clinical Operations Consultant to partner with various teams for the successful planning and execution of clinical trials. The role involves managing trials, overseeing CROs and vendors, and ensuring compliance with guidelines while maintaining strong relationships with stakeholders.
BiotechnologyPharmaceuticalRecruitingStaffing Agency
Hiring Manager
Ashley Teixeira, MSc.
Responsibilities
Support the Study Lead and Study Execution Team in initiating and managing trials per SOPs, FDA, and ICH/GCP guidelines
Oversee selection and performance of CROs and vendors, including RFP development, bid defenses, and contract management
Monitor site performance, recruitment, and quality metrics; resolve issues with internal and CRO teams
Contribute to study document development (protocols, ICFs, CRFs, study manuals, CSRs)
Manage study budgets, forecasts, and vendor invoices in partnership with Finance
Implement and maintain clinical systems (CTMS, TMF, EDC, IRT) and ensure inspection readiness
Conduct data reviews, risk assessments, and implement mitigation strategies
Build strong relationships with internal teams, CROs, and clinical sites; provide training as needed
Support audits, TMF quality checks, and other operational initiatives
Qualification
Required
Remote - west coast are required
5+ years of recent oncology experience required
5+ years of sponsor environment experience rather than a CRO required
Bachelor's in Life Sciences or related field; 6+ years in clinical development
Proven expertise in global clinical and vendor management; oncology experience required
Strong organizational, analytical, and communication skills; proactive problem solver
Collaborative, detail-oriented, and adaptable in a fast-paced environment
Ability to travel up to 10%
Preferred
Early-phase and precision medicine trial experience preferred
Company
BioPhase
BioPhase Solutions specializes in staffing and recruiting professionals for pharmaceutical, biotech and medical device companies.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase