Clinical Trial Manager

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.

This position provides an opportunity to join a rapidly growing Clinical Operations organization and contribute substantially to the building of the department and the successful implementation of trials.

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 Investigator Brochure.
• Lead day-to-day management of external vendors as needed to support the trial design and implementation
• Review and approval of internal and external vendor study plans and processes
• Review monitoring reports and interact with CRO to ensure the quality of monitoring and site management
• Work with 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 in routine meetings with the CRO and service providers

Qualifications:

• BA/BS; Life Science degree a plus
• Work experience to include a minimum of 5 years clinical trial experience with a solid understanding of functional area responsibilities associated with the clinical development process.
• Good working knowledge of GCP, ICH 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, are required.
• Additional attributes include an ability to multi-task, be flexible, and to thrive in a fast-paced environment
• Exceptional collaboration, communication, and interpersonal skills
• Demonstrated ability to effectively manage external vendors & CROs
• Advanced proficiency in Microsoft Office and Microsoft Project or Smartsheet
• Demonstrated strong written and verbal communication skills
• Must be able to travel

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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