Senior Clinical Trial Manager

The role

The Senior Clinical Trial Manager manages the planning, execution, and oversight of one or more clinical trials across all phases of development. This role acts as an operational lead to ensure trial milestones are met on time, within budget, and in alignment with regulatory and quality standards.

What you will do

• Serve as the primary operational lead for assigned clinical trials
• Oversee CROs and vendors from study start-up through close-out
• Lead cross-functional trial teams to ensure alignment on timelines, deliverables, risk mitigation, and study objectives
• Manage protocol development, site selection, study conduct, monitoring, data review, and database lock
• Oversee and review key clinical trial documents
• Monitor CRO performance regarding study plans, timelines, budgets, and quality expectations
• Lead development and review of study plans and vendor SOPs
• Ensure timely data query resolution and review of protocol deviations
• Maintain high-quality Trial Master Files and ensure inspection readiness
• Mentor or manage junior team members and contribute to departmental process improvements

Required qualifications

• 8+ years of clinical trial experience, including direct management of CROs and vendors
• Proven ability to lead cross-functional study teams and drive clinical programs forward independently
• Deep understanding of GCP, ICH guidelines, and regulatory frameworks relevant to global clinical trial management
• Strong problem-solving, organizational, and analytical skills
• Excellent written and verbal communication skills
• Ability to manage multiple priorities in a fast-paced environment and lead initiatives with minimal oversight
• Proficient in Microsoft Office Suite
• Working knowledge of project management tools (e.g., MS Project, Smartsheet)
• Must be able to travel as needed
• Bachelor’s degree in life sciences or a related field with 8+ years of work experience

Nice to have

• Biotech experience
• Obesity experience

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants

About the company

Kailera is working to advance novel therapies for obesity and related conditions. The company is rooted in an entrepreneurial spirit and a team-oriented culture.