Clinical Trial Manager — Onsite Waltham | Growth & Equity

Kailera Therapeutics; Massachusetts; On-site; USD 127,000 - 155,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Equity grants

Annual bonus opportunities

Job summary

Kailera Therapeutics in Waltham, MA is seeking a Clinical Trial Manager to lead daily management of clinical trial activities and oversee CRO relationships, ensuring study start-up, conduct, and completion.

The role requires at least 6 years of trial experience, strong ICH-GCP knowledge, excellent communication, and ability to travel; onsite 3-4 days per week with a supportive, fast-paced environment.

Qualifications

• Minimum 6 years of clinical trial experience with a solid understanding of the clinical development process.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements for clinical trial management.
• Must have strong study management, communication (oral and written), and analytical skills.
• Excellent interpersonal skills; able to work in a team environment as well as independently.
• Ability to multi-task, be flexible, and thrive in a fast-paced environment.
• Demonstrated ability to manage external vendors & CROs.
• Advanced proficiency in Microsoft Office and Microsoft Project or other PM software.
• Must be able to travel.

Responsibilities

• Lead interface with the CRO regarding status of project activities and deliverables (site identification/selection, pre-study activities, enrollment, management/conduct, database lock, post-study activities).
• Collaborate with cross-functional clinical trial team to review and prepare various study documents including protocol, model informed consent forms, and study plans.
• Lead day-to-day management of external vendors to support trial design and implementation.
• Review and approve internal and external vendor study plans and processes, as applicable.
• Review monitoring reports and interact with CRO to ensure quality of monitoring and site management.
• Work with cross-functional team to ensure data query management and data retrieval in a timely manner.
• Review deviation listings and site audit reports and work with team to resolve site issues.
• Maintain and ensure the quality and completeness of study master files in compliance with GCP.
• Lead Clinical Study Team meetings internally, and/or with CRO and service providers.

Skills

Clinical trial management

ICH-GCP knowledge

Communication skills

Team collaboration

Multi-tasking

Vendor management

MS Office / MS Project

Travel readiness

Education

BA/BS in Life Sciences

Job description

Kailera Therapeutics in Waltham, MA is seeking a Clinical Trial Manager to lead daily management of clinical trial activities and oversee CRO relationships, ensuring study start-up, conduct, and completion.

The role requires at least 6 years of trial experience, strong ICH-GCP knowledge, excellent communication, and ability to travel; onsite 3-4 days per week with a supportive, fast-paced environment.