Senior Clinical Trial Manager

What You’ll Do:

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 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.

 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

 

Responsibilities:

• 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

 

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 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

 

Preferred Qualifications:

• Biotech experience preferred

 

Education:

• Bachelor’s degree in life sciences or a related field with 8+ years of work experience; or an advanced degree with 2+ years of experience