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Associate Director, Clinical Data Management

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Kailera Therapeutics

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Location:
United States, Waltham

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

160000.00 - 200000.00 USD / Year
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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • At least 10 years of experience in clinical data management, including direct collaboration with CROs and data management vendors
  • 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
  • Bachelor’s degree or higher in Life Science or related discipline

Nice to have:

  • Experience in global or cross-cultural environments is preferred
  • 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
What we offer:
  • 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

Additional Information:

Job Posted:
December 09, 2025

Employment Type:
Fulltime
Work Type:
Hybrid work
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