Compass Consulting · 1 week ago
Clinical Trial Lead
San Francisco, CA
Contract
Hybrid
Senior Level, Lead/Staff
$100/hr - $116/hr
10+ years expCompass Consulting is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates aimed at improving patient outcomes. They are seeking a Clinical Trial Lead to oversee complex trials, manage cross-functional teams, and ensure excellence in clinical development.
BiotechnologyConsultingLife ScienceMedical DevicePharmaceuticalRecruitingStaffing Agency
Hiring Manager
Jay Hite
Responsibilities
Lead and support end-to-end clinical trial activities, managing budgets, timelines, and resources with a focus on quality and operational efficiency
Develop and oversee clinical operational plans aligned with study objectives, ensuring regulatory compliance (ICH/GCP), SOP adherence, and inspection readiness
Oversee vendor selection, management, and performance, including CRO oversight, site feasibility assessments, and regulatory submissions
Collaborate on clinical documentation such as protocols, investigator brochures, and study reports, ensuring clarity and compliance
Represent Clinical Operations in cross-functional project teams, external stakeholder meetings, and regulatory inspections
Monitor study progress, communicate status, costs, and issues to senior management to facilitate timely decision-making
Lead quality initiatives, SOP development, and continuous process improvements to optimize clinical trial execution
Manage and mentor Clinical Operations staff, fostering development, performance, and a cohesive team environment
Build and maintain strong relationships with investigators, site staff, key opinion leaders, and external partners
Qualification
Required
Minimum of 10 years' experience in pharmaceutical development, with proven success managing CROs and clinical trials
At least 3 years of people management experience, including hiring, coaching, and performance evaluation
Extensive knowledge of GCP, ICH guidelines, and regulatory standards; GCP inspections/audits experience highly desired
Excellent organizational, problem-solving, and project management skills; adept at handling complex situations and data analysis
Strong written and verbal communication abilities, with proficiency in Microsoft Office Suite (Project, Word, Excel, Visio, PowerPoint)
Ability to work independently, demonstrate initiative, and collaborate effectively within cross-functional teams
Bachelor's degree in a scientific discipline is required; a Master's degree is preferred
Willingness to travel as required based on business needs
Open to candidates across all locations, with availability for PST hours as needed
Proven leadership qualities aligned with our core values and a commitment to innovation
Preferred
Experience with inspection readiness and audit processes
Advanced project management certifications or training
Prior experience in a start-up or fast-paced pharmaceutical environment
Multilingual capabilities or international trial experience
RN or BSN degree highly desired; equivalent experience may be accepted
Demonstrated success in managing multiple clinical trials and cross-functional teams in a regulated environment
Company
Compass Consulting
Compass Consulting is a life science staffing and consulting firm serving the needs of biotech, medical device and pharmaceutical companies.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Brett F.
Managing Partner
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