Associate Director - Clinical Data Management

Job Summary:

The Associate Director, Clinical Data Management Leads clinical data management activities across one or more clinical programs, ensuring the timely delivery of high-quality, audit-ready clinical trial data in support of regulatory submissions and clinical development timelines. Acts as the primary data management point of contact for assigned programs, overseeing CRO and vendor performance, database design, and data cleaning strategy from study start-up through database lock. Partners closely with Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Pharmacovigilance and Quality to ensure data management deliverables align with study milestones, data quality objectives and inspection-readiness standards. This role combines deep technical data management expertise with the leadership skills needed to guide cross-functional teams and external vendors toward consistent, high-quality outcomes. This role reports to the Director, Clinical Data Management.

Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Oversee the development and review of key data management study documents such as Data Management Plans, CRF/eCRF design specifications, data validation plans, custom listings/reports, and data cleaning plans.
• Oversee EDC and other clinical data systems build in support of protocol objectives, site-level and patient-level data entry workflows, user acceptance testing (UAT), database releases, mid-study updates, interim snapshots and database lock activities.
• Monitor clinical data quality, study metrics and KPIs to ensure timely and accurate data cleaning, discrepancy management, medical coding (MedDRA, WHO Drug), and reconciliation of external data sources (e.g., central labs, eCOA, safety data).
• Contribute to internal and external cross-functional study team meetings by communicating study status, proactively identifying risks to timelines, data quality, and regulatory compliance, and recommending mitigation strategies.
• Ensure all data management activities comply with ICH E6(R3) GCP guidelines, 21 CFR Parts 11 and 312, data security, privacy (e.g., GDPR, HIPAA) and other applicable global regulatory requirements.
• Contribute to process improvement initiatives, SOP development, and data management standards across programs.
• Strong understanding of CDISC standards CDASH/SDTM, statistical analysis dataset specifications, and submission-ready data packages.
• Support preparation for regulatory inspections and audits by maintaining complete documentation of data management activities and sponsor oversight and ensure regular documentation filings into the Trial Master File.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Bachelor’s degree in Life Sciences, Health Sciences, Computer Science, or a related discipline, or equivalent education and experience.
• Minimum of 7 years of progressive experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry.
• Experience in immunology or autoimmune therapeutic areas preferred
• Proven experience managing CDM activities across all phases of clinical development (Phase I–III), including late-stage and/or registration-enabling trials.
• Prior experience managing CRO relationships and overseeing outsourced CDM activities
• Proficiency with EDC platforms (e.g., Medidata Rave, Veeva Vault EDC) and CDISC (CDASH/SDTM/ADaM) standards.
• Working knowledge of data cleaning, query management, and database lock processes.
• Proficiency in medical coding dictionaries (MedDRA, WHO Drug) and coding conventions.
• Familiarity with centralized data review methodologies such as data visualizations and review tools for identifying data quality trends and leveraging risk-based monitoring (RBM) approaches.
• Ability to lead cross-functional study teams and manage CRO performance without direct reporting authority.
• Strong written and verbal communication for cross-functional and vendor collaboration.
• Ability to present data management status and risks to program leadership.
• Skilled at translating technical data issues into clear, actionable summaries for non-DM stakeholders.
• Effective at facilitating technical system design discussions and data quality oversight review meetings with internal and external cross-functional team members

Salary Range 181000 - 235000 USD