Senior Clinical Trial Manager Jobs

Kailera Therapeutics

Location:
United States, Waltham

Category:
Research and Development

Contract Type:
Not provided

Salary:

136000.00 - 170000.00 USD / Year

Save Job

Apply Position

Job Description:

The Senior Clinical Trial Manager (Sr. CTM) will manage the planning, execution, and oversight of one or more clinical trials across all phases of development. Acting as a key operational lead, the Sr. CTM will be responsible for ensuring that trial milestones are met on time, within budget, and in alignment with regulatory and quality standards. This role requires a proactive, solution-oriented professional who can collaborate cross-functionally and manage external partners with minimal oversight. The Sr. CTM will also play a critical role in process improvements and the continued development of clinical operations at Kailera.

Job Responsibility:

Serve as the primary operational lead for assigned clinical trials
accountable for end-to-end trial execution, including oversight of 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
Independently manage key trial activities, such as protocol development, site selection, study conduct, monitoring, data review, and database lock
Oversee and review key clinical trial documents (e.g., informed consent forms, investigator brochures, monitoring plans), ensuring quality and regulatory compliance
Monitor CRO performance to ensure adherence to study plans, timelines, budgets, and quality expectations
escalate and resolve issues proactively
Lead development and review of study plans and vendor SOPs
ensure appropriate documentation and risk mitigation strategies are in place
Ensure timely data query resolution, review of protocol deviations, and follow-through on site-related corrective actions
Maintain high-quality Trial Master Files and ensure inspection readiness throughout the study lifecycle
Mentor junior team members and contribute to departmental process improvements and knowledge-sharing initiatives
Collaborate with QA, Regulatory, and cross-functional stakeholders to ensure continuous compliance with GCP, ICH, and global regulatory guidelines

Requirements:

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 with the ability to anticipate challenges and implement solutions
Excellent written and verbal communication skills, including stakeholder presentations and vendor negotiations
Ability to manage multiple priorities in a fast-paced environment and lead initiatives with minimal oversight
Proficient in Microsoft Office Suite, and 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

Nice to have:

Biotech experience preferred
Advanced degree is a plus

What we offer:

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Additional Information:

Job Posted:
December 09, 2025

Employment Type:

Fulltime

Work Type:

Hybrid work

View All Jobs In This Company

Job Link Share:

Senior Clinical Trial Manager