Clinical Trial Manager

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

Benefits offered by this job

Health coverage

401(k) match

Tuition reimbursement

Equity grants

Annual bonus opportunities

Job summary

Kailera Therapeutics, Inc. in Waltham, MA is seeking a Clinical Trial Manager to lead and coordinate trial activities, oversee CROs and service providers, and ensure study start-up through completion.

The role requires 6+ years in clinical trial management, strong ICH-GCP knowledge, vendor oversight, and excellent communication; travel is required, onsite 3-4 days per week.

Qualifications

• 6+ years of clinical trial experience with understanding of development process
• Strong knowledge of ICH-GCP guidelines and regulatory requirements
• Excellent written and oral communication skills
• Ability to work in a team and independently in a fast-paced environment
• Experience managing external vendors & CROs
• Proficiency with MS Office and project management software

Responsibilities

• Lead interface with CRO regarding status of project activities and deliverables
• Collaborate with cross-functional team to review and prepare study documents
• Manage external vendors to support trial design and implementation
• Review study plans and processes for internal and external vendors
• Review monitoring reports and ensure quality of monitoring and site management
• Ensure data query management and timely data retrieval
• Resolve site issues such as retraining and resource needs
• Maintain study master files in compliance with GCP
• Lead Clinical Study Team meetings with CROs and providers

Skills

Clinical trial management

ICH-GCP

Vendor management

Microsoft Project

Communication

Tools

Microsoft Office

Microsoft Project

Job description

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

The Clinical Trial Manager will provide project support to team members by leading and/or participating in the daily management of clinical trial activities. Successful candidate will be working closely with and will be responsible for oversight of study activities through our CROs and service providers, including study start-up, conduct, and completion.

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

Responsibilities:

• Perform as the lead interface with the CRO regarding status of project activities and deliverables (including but not limited to site identification and selection, pre-study activities, enrollment, management/conduct, database lock, post-study activities)
• Collaborate with the cross-functional clinical trial team to review and prepare various clinical study documents including but not limited to study protocol, model informed consent forms, and study plans
• Lead day-to-day management of external vendors, as needed, to support the 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 the quality of monitoring and site management
• Work with cross-functional team to ensure data query management and data retrieval is taking place in a timely manner
• Review deviation listings and site audit reports and work with team to resolve site issues (e.g., staff retraining, additional resources)
• 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

Required Qualifications:

• Work experience to include a minimum of 6 years clinical trial experience with a solid understanding of functional area responsibilities associated with the clinical development process
• Good working knowledge of ICH-GCP guidelines and regulatory requirements for clinical trial management
• Must have strong clinical study management, communication (oral and written), and analytical skills
• Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently
• Additional attributes include an ability to multi-task, be flexible, and to thrive in a fast-paced environment
• Demonstrated ability to effectively manage external vendors & CROs
• Advanced proficiency in Microsoft Office and Microsoft Project or other Project Management software
• Demonstrated strong written and verbal communication skills
• Must be able to travel

Education:

Salary Range

$127,000 - $155,000 USD

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

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