[Hiring] Associate Director, Clinical Data Management Programmer @AVENZO THERAPEUTICS INC

Role Description

Reporting to the Senior Director, Data Management, the Associate Director, Clinical Data Management (CDM) Programmer will lead and oversee clinical data management activities across our clinical programs, ensuring the delivery of high-quality, compliant, and timely clinical trial data. This role serves as a hands-on leader and subject matter expert, partnering closely with Clinical Development, Biometrics, Medical, Regulatory, and external vendors to support decision-making and regulatory submissions.

• Lead and oversee end-to-end clinical data management activities across assigned clinical programs, from study start-up through database lock and study close-out.
• Define programming strategy, standards, and best practices for inspection-ready deliverables, including edit checks, derivations, custom functions, and automated data review tools.
• Generate data listings, reconciliation outputs, and other programmed deliverables to support clinical data management and biostatistics.
• Direct the design, development, validation, and oversight of clinical data capture systems, ensuring data integrity and effective Contract Research Organization (CRO) oversight.
• Oversee database build, User Acceptance Testing (UAT), data cleaning, medical coding, and database lock activities, ensuring timelines and quality expectations are met.
• Serve as the clinical data management subject matter expert and study-level lead on cross-functional teams, partnering closely with Clinical Development, Biometrics, Clinical Operations, Medical, Regulatory, Quality, and Compliance.
• Apply risk-based data management and quality oversight methodologies to proactively identify, assess, and mitigate data-related risks.
• Manage CROs and external data vendors, including scope definition, performance monitoring, and issue escalation/resolution.
• Ensure data management processes, documentation, and vendor deliverables comply with applicable regulations and standards (e.g., ICH-GCP, 21 CFR Part 11, GCDMP).
• Support inspection readiness and participate in audits and regulatory inspections as required.
• Develop and maintain reusable programming assets (e.g., SAS macros) and automated outputs (listings/tables/visualizations) to support ongoing and ad hoc data review.
• Provide technical leadership and guidance on clinical database structure, data standards, and downstream data use to internal teams and external vendors.
• Ensure all programming outputs meet CDISC standards (e.g., SDTM/ADaM) and regulatory expectations.
• Maintain study-level data management documentation in an audit-ready state and oversee quality-controlled filing within the electronic Trial Master File (eTMF).
• Proactively identify issues impacting study timelines, milestones, or data quality and implement effective mitigation strategies.
• Contribute to the development, implementation, and continuous improvement of Clinical Data Management SOPs, standards, and best practices.
• Support Clinical Operations, Biostatistics, and Data Management by providing data insights and solving complex technical and programming challenges.

Qualifications

• Bachelor’s degree in Life Sciences or Computer Science required, or a related area degree preferred (e.g., MBA) with 10+ years of progressive Clinical Data Management experience in the life sciences industry or an equivalent combination of academic and industry experience.
• Proficiency in SAS programming; experience with SQL, R, or Python is an advantage.
• Strong understanding of clinical data management processes, including EDC design, data cleaning, query management, and database lock procedures.
• Hands-on experience with CDISC standards (CDASH, SDTM) and data readiness for regulatory submissions.
• Recognized for consistently delivering high-quality programming outputs, mentoring junior programmers, and improving CDM processes through automation and standardization.
• Proficient with various data collection and Electronic Data Capture (EDC) systems.
• Experience managing CROs and external vendors in a sponsor oversight mode.
• Strong knowledge of clinical research, regulations and industry standards (e.g. FDA/ICH, ICH-GCP, 21 CFR Part 11, GCDMP).
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
• Strong analytical and problem-solving abilities, with a strategic mindset.
• Promote knowledge sharing, documentation, and consistent application of programming standards.

Requirements

• This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel.

Benefits

• Employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance.
• Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness.
• Employees will also be able to enroll in the Company’s 401(k) plan.
• Employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked.
• Employees enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies.