Associate Director, Clinical Systems

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:

Associate Director, Clinical Systems (ADCS) is responsible for partnering with Kailera clinical technology systems supporting clinical trials including, but not limited to, data analytics tools, Risk Based Quality Management systems and Trial Master File technology. The ADCS is involved in the planning, implementation, and maintenance of clinical systems to enable the  execution and delivery of clinical programs.  The ADCS will also lead departmental initiatives; This role also oversees the Trial Master File service provider and process across trials, is responsible for data analytic reporting for TMF and vendor Key Performance Indicators and trending in to drive continuous improvement.  The ADC will also monitor the emergence of new technologies and evaluate its potential use in the Kailera portfolio.

 

Responsibilities:

• Acts as Business Owner for the Veeva eTMF system, managing periodic  enhancements, system issues, interfacing with Kailera IT, FSP Veeva Administrators and Veeva Managed and Professional Services.
• Oversees the management of the Trial Master file process across studies, including oversight of TMF plan template, managing TMF CRO and vendor activities, analyzing TMF data, study/program/CRO level reporting, and leading monthly TMF health checks.
• Collaborates with Kailera IT and Kailera end users to design, develop and deploy clinical operations data analytics studies, identifying trends and surfacing issues to provide actionable insights to study team members
• Acts as business owner for the operational analytics platform, building processes, gathering requirements from key stakeholders and ensuring quality output. 
• Oversees Risk Based Quality Management (RBQM) execution for Clinical Development Operations.
• Oversees management of Functional Service Provider execution of eTMF activities, in accordance with Kailera SOPs, ICH Guidelines, and Good Clinical Practice (GCP).
• Responsible for review and approval of vendor invoices
• Analyzes vendor operational data against Key Performance Indicators to identify performance issues; coordinates with others on the Clinical Oversight team, Clinical Quality Management and the study team to remediate issues and track to resolution as needed.
• Acts on behalf of Business Operations on cross-functional project teams; interacts with internal and external groups.

 

Required Qualifications:

• 8+ years of relevant industry experience and at least 3 years of involvement with multi-disciplinary study teams. Alternatively, must have proven experience in all primary job functions.
• 3-5+ years of clinical study experience with global clinical studies.
• Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials.
• Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
• Ability to lead cross-functional teams on special projects to drive to expected result
• Demonstrated ability to manage and motivate team members (e.g., internal staff and external investigators/consultants).

 

Preferred Qualifications:

• Experience in oversight of CROs, vendors and consultants.
• Experience with Veeva eTMF, Veeva Site Connect and Veeva Study Training
• Experience with other study support systems, i.e., data analytics, e-consent, etc.

 

Education:

• Minimum of a bachelor’s degree in a life science or a health-related field or equivalent experience
• Relevant professional certifications a plus

 

 

 

Benefits of Working at Kailera

In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.

• Comprehensive health benefits and tax-advantaged savings accounts
• Flexible time off, 13 paid holidays, and a companywide year-end sh