Associate Director, Clinical Data Management

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 Associate Director, Clinical Data Management plays a key role within the Clinical Development Operations by providing strategic oversight of outsourced clinical trials. This position is responsible for developing and executing project plans for outsourced studies and ensuring vendor activities meet defined quality standards and timelines. As the primary data management representative on the study management team, the Associate Director coordinates ongoing DM activities, partnering closely with key stakeholders to implement a robust and transparent data strategy. They collaborate with CRO and vendor DM leads to drive timely, high-quality data delivery. This role reports to the Head of Clinical Data Management.

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

Responsibilities:

• Provide project-level leadership for clinical data management (CDM) activities, monitor and report on overall study progress
• Develop and maintain study timelines and ensure timely delivery of data-related milestones in collaboration with cross-functional teams and external vendors
• Oversee the creation of study-specific CDM documentation, including eCRF specifications, completion guidelines, edit check specifications, and data management plans—proactively identifying and mitigating risks to data quality and ensuring appropriate filing in the Trial Master File (eTMF)
• Manage CRO CDM counterparts to ensure compliance with scope of work, contractual agreements, timelines, and quality standards
• Conduct end-to-end testing of electronic case report forms (eCRFs), including authoring and executing User Acceptance Test (UAT) plans and scripts prior to deployment
• Develop and execute risk mitigation and action plans as needed to maintain data integrity and operational efficiency
• Actively participate in internal study team discussions and engage with external stakeholders through vendor teleconferences
• Serve as a primary liaison to internal partners (Clinical Operations, Biometrics, Safety/Pharmacovigilance, Regulatory Affairs) and external entities (CROs, third-party data vendors)
• Monitor vendor performance and quality; escalate issues to management and implement corrective actions as appropriate
• Support audit and inspection readiness activities at the study level

Required Qualifications:

• At least 10 years of experience in clinical data management, including direct collaboration with CROs and data management vendors; experience in global or cross-cultural environments is preferred
• Comprehensive knowledge of FDA and ICH/GCP regulations and their application to data management processes
• Proficiency in CDISC standards (CDASH/SDTM), medical coding dictionaries, 21 CFR Part 11 compliance, and industry best practices in clinical data management
• Exceptional interpersonal, communication, and organizational abilities, with a demonstrated capacity to manage multiple programs and workflows in a dynamic, team-oriented setting
• Proven success in managing vendor relationships and functional service provider (FSP) partnerships
• Strong track record of building effective relationships and managing expectations with external partners and vendors
• Practical experience with electronic Trial Master File (eTMF) systems related to CDM documentation

Preferred Qualifications:

• Experience with regulatory submissions (e.g., IND, NDA/BLA, MAA) and associated data packages
• Familiarity with emerging technologies in clinical data management such as eSource, decentralized trials, and real-time data analytics

Education:

• Bachelor's degree or higher in Life Science or related discipline

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 shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Disability and life insurance

At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.

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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