Senior Clinical Trial Manager - Remote/Hybrid

kailera; United States; Hybrid; USD 143,000 - 175,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Annual bonus opportunities

Equity grants

Year-end shutdown

Job summary

Kailera Therapeutics, Inc. is seeking a Senior Clinical Trial Manager to lead end-to-end trial execution, manage CROs and vendors, and drive global study progress.

The role supports on-site hub work in Waltham, MA or remote work with periodic hub visits, within a fast-paced, compliant clinical operations environment. Responsibilities include leading cross-functional teams, protocol development, monitoring plans, and regulatory documentation, with a focus on quality and timely delivery across

Qualifications

• Bachelor's degree in life sciences or a related field with 8+ years of work experience.
• 8+ years of clinical trial experience with CRO/vendor management.
• Strong leadership of cross-functional study teams and independent program drive.
• Deep understanding of GCP, ICH guidelines, and regulatory frameworks for global clinical trials.
• Excellent written and verbal communication, including stakeholder presentations and vendor negotiations.

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; elevate and resolve issues proactively.
• Lead development and review of study plans and vendor SOPs; ensure appropriate documentation and risk mitigation strategies.
• 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 or manage 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.

Skills

8+ years clinical trial experience and

CRO/vendor management

Cross-functional leadership

GCP/ICH knowledge

Regulatory knowledge

Communication skills

Project management

Travel readiness

Education

Bachelor's degree in life sciences

Tools

MS Project

Smartsheet

Job description

Kailera Therapeutics, Inc. is seeking a Senior Clinical Trial Manager to lead end-to-end trial execution, manage CROs and vendors, and drive global study progress.

The role supports on-site hub work in Waltham, MA or remote work with periodic hub visits, within a fast-paced, compliant clinical operations environment. Responsibilities include leading cross-functional teams, protocol development, monitoring plans, and regulatory documentation, with a focus on quality and timely delivery across