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 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.

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; advanced degree is a plus