10+ years of hands-on clinical trial experience across multiple Clinical Operations roles (CTA, CRA, CTM, CPM).
3+ years of direct people management experience.
Experience with in-house site monitoring and clinical trial execution.
Strong knowledge of ICH-GCP, FDA/EMA regulations, and clinical trial lifecycle.
Proven ability to manage and develop Clinical Operations staff at various seniority levels.
Excellent organizational, communication, and problem-solving skills.
Experience with inspection readiness, audits, and CAPA follow-up.
Responsibilities
Manage, coach, and develop a team of 6-12 clinical staff across various roles.
Conduct performance reviews and career development planning for team members.
Lead recruitment, onboarding, and training for new hires.
Allocate staff based on trial phase and complexity.
Monitor team capacity and escalate resourcing issues as needed.
Ensure adherence to ICH-GCP, SOPs, and regulatory requirements.
Provide hands-on guidance for site management and trial execution.
Benefits
Flexible work location (Mountain View, CA or Remote in the US).
Opportunity for professional development and training.
Engagement in a hands-on, in-house clinical trial environment.
Collaboration with cross-functional teams in a dynamic setting.
Travel opportunities (approximately 25-30%).
Full Job Description
Primary Role
The Senior Manager, Clinical Operations provides line management and functional oversight for a team of clinical trial staff spanning Clinical Trial Associate (CTA), Clinical Research Associate (CRA), Clinical Trial Manager (CTM), and Clinical Project Manager (CPM) levels. Trials are run in-house rather than outsourced to a CRO, so this role and its team hold direct, hands-on responsibility for site management, monitoring, and trial execution rather than oversight of a CRO's delivery. This role is responsible for staff development, workload/resource allocation across assigned studies or programs, and ensuring consistent quality and process adherence across the team, while individual contributors retain day-to-day accountability for their assigned trials.
What you'll do
People Management
Directly manage, coach, and develop a team of 6-12 clinical staff across CTA, CRA, CTM, and CPM levels
Conduct performance reviews, goal setting, and career development planning tailored to each direct report's role and level
Lead recruitment, onboarding, and training for new team members
Identify training needs and coordinate role-specific development (e.g., TMF management for CTAs, site monitoring for CRAs, vendor oversight for CTMs, cross-functional leadership for CPMs)
Resource & Workload Management
Allocate staff across studies based on trial phase, complexity, and enrollment status
Monitor team capacity and escalate resourcing gaps or overallocation to the Director/Senior Director
Support study budgeting and FTE planning in partnership with Clinical Operations leadership
Operational & Quality Oversight
Ensure team members follow ICH-GCP, SOPs, and applicable regulatory requirements across assigned trials
Review and approve key study deliverables (monitoring plans, TMF completeness, site management plans) as appropriate to level
Provide direct, hands-on guidance on site selection, initiation, monitoring, and close-out - activities performed in-house by the team's CRAs and CTMs rather than a CRO
Serve as an escalation point for site-level or protocol-execution issues that direct reports cannot resolve independently
Partner with QA on audit/inspection readiness and CAPA follow-up for the team's studies
Cross-Functional Collaboration
Represent Clinical Operations staffing and capacity needs in program-level planning meetings
Partner with Clinical Development, Regulatory, Biostatistics, and Data Management leads to align trial execution with program timelines
Provide input to senior leadership on process improvements and standardization across trials
Location
Mountain View, CA or Remote (US)
Salary Range $170,000 - $185,000
*depending on qualifications and experience level
Travel Required
Travel required (approximately 25-30%)
Qualifications
Required Skills/Abilities:
10+ years of hands-on clinical trial experience across multiple Clinical Operations roles, including CTA, CRA, CTM, and/or CPM experience.
3+ years of direct people management experience.
Direct experience with site monitoring, site management, and clinical trial execution in an in-house operating model.
Strong working knowledge of ICH-GCP, FDA/EMA regulations, and the clinical trial lifecycle.
Demonstrated experience managing and developing Clinical Operations staff across varying levels of seniority.
Strong organizational, communication, and problem-solving skills, with the ability to manage competing priorities across multiple studies.
Experience with inspection readiness, audits, and CAPA follow-up.
Experience supporting multiple clinical programs or studies simultaneously.
Bonus Skills/Abilities:
Experience building or improving Clinical Operations processes, tools, and ways of working in a growing biotech environment.
Supervisory Responsibilities:
Directly manages, coaches, and develops Clinical Operations staff across CTA, CRA, CTM, and CPM levels, including performance management, goal setting, career development, and workload allocation.
Education and Experience:
Bachelor's degree in life sciences, nursing, or related field (advanced degree a plus)
Physical Requirements:
Required to sit for prolonged periods of time.
Ability to travel domestically and internationally.
While performing the duties of this job, the noise level in the work environment is usually
