Clinical Trial Manager: Onsite Lead, CRO & Vendors

Kailera Therapeutics; Waltham (MA); On-site; USD 127,000 - 155,000; Full time

Job summary

Kailera Therapeutics in Waltham, MA, is seeking a Clinical Trial Manager to lead and participate in daily clinical trial activities, overseeing study start-up, conduct, and completion with CROs and service providers.

The role is hub-based and onsite 3–4 days per week, supporting rapid growth of the Clinical Operations team. A BA/BS in Life Sciences and at least 6 years of trial experience are required, with strong ICH-GCP knowledge and excellent communication skills.

Qualifications

• Minimum 6 years of clinical trial experience in the development process.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements for clinical trial management.
• Excellent written and verbal communication and analytical skills.
• Ability to multi-task, work in a fast-paced environment, and travel as required.
• Advanced proficiency in Microsoft Office and Project or similar PM software.

Responsibilities

• Serve as lead interface with CRO for project status, deliverables, site identification, enrollment and conduct.
• Collaborate with cross-functional trial teams to review study documents (protocols, ICFs, study plans).
• Lead management of external vendors to support trial design and execution.
• Review vendor study plans and processes; ensure quality of monitoring and site management.
• Ensure data query management and timely data retrieval; resolve site issues with team.

Skills

Project management

Written communication

Verbal communication

Analytical skills

Travel flexibility

Education

BA/BS in Life Sciences

Tools

Microsoft Office

Microsoft Project

Job description

Kailera Therapeutics in Waltham, MA, is seeking a Clinical Trial Manager to lead and participate in daily clinical trial activities, overseeing study start-up, conduct, and completion with CROs and service providers.

The role is hub-based and onsite 3–4 days per week, supporting rapid growth of the Clinical Operations team. A BA/BS in Life Sciences and at least 6 years of trial experience are required, with strong ICH-GCP knowledge and excellent communication skills.