Senior Clinical Operations Leader - In-House Trials

Alto Neuroscience, Inc.; Mountain View (CA); Remote; USD 170.000 - 185.000; Vollzeit

Zusammenfassung

Alto Neuroscience, Inc. is seeking a Senior Manager, Clinical Operations to lead a hands-on team of trial staff. You will direct site monitoring, trial execution, and staff development in an in-house model, not CRO-led.

The role focuses on program-level staffing, quality, and cross-functional alignment in a fast-growing biotech environment. You will mentor CTAs, CRAs, CTMs, and CPMs, oversee budget planning, and drive process improvements while ensuring regulatory compliance and high-quality

Qualifikationen

• 10+ years of hands-on clinical trial experience across multiple Clinical Operations roles.
• 3+ years of direct people management experience.
• In-house trial execution with site monitoring and management.
• Strong knowledge of ICH-GCP, FDA/EMA regulations.
• Experience with inspections, audits, and CAPA follow-up.
• Ability to manage multiple programs simultaneously.

Aufgaben

• 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.
• Lead recruitment, onboarding, and training for new team members.
• Allocate staff across studies based on trial phase, complexity, and enrollment status.
• Monitor team capacity and address resourcing gaps or over-allocation.
• Support study budgeting and FTE planning with Clinical Operations leadership.
• Ensure team compliance with ICH-GCP, SOPs, and regulatory requirements.
• Review and approve key study deliverables and TMF completeness.
• Provide hands-on guidance on site selection, initiation, monitoring, and close-out.
• Escalate site-level or protocol-execution issues as needed.
• Partner with QA on audit readiness and CAPA follow-up.
• Represent staffing needs in program-level planning, collaborating with regulatory and data leads.
• Provide input to leadership on process improvements.

Kenntnisse

Clinical trial experience

People management

Site monitoring

In-house operations

ICH-GCP knowledge

Audits & CAPA

Multiple programs

Process improvement

Ausbildung

Bachelor's degree in life sciences / related field

Jobbeschreibung

Alto Neuroscience, Inc. is seeking a Senior Manager, Clinical Operations to lead a hands-on team of trial staff. You will direct site monitoring, trial execution, and staff development in an in-house model, not CRO-led.

The role focuses on program-level staffing, quality, and cross-functional alignment in a fast-growing biotech environment. You will mentor CTAs, CRAs, CTMs, and CPMs, oversee budget planning, and drive process improvements while ensuring regulatory compliance and high-quality