Clinical Trial Manager

Kailera Therapeutics•Waltham, MA

9d•Hybrid

About The Position

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. 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.

Requirements

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
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
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
BA/BS; Life Science degree a plus

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