Associate Director, Clinical Data
About The Position
The Associate Director, Clinical Data is the sponsor’s data management lead for every company-sponsored study across Clinical Development and Medical Affairs. Data management is outsourced to CROs and specialty vendors; this role establishes standards, oversees vendor delivery, and owns sponsor accountability for data quality from database design through database lock. The role works closely with study leads and the Biostatistician to ensure data are fit for analysis, submission, and publication. The position oversees sponsor review and approval of data management plans and related study data deliverables, EDC build and user acceptance testing, vendor performance, external-data integration, medical coding, ongoing data review, and database-lock readiness. It also promotes consistent data standards across the portfolio, defines data collection approaches for Phase 3b/4 and observational studies, maintains data-management TMF artifacts, supports audits and inspections, and contributes to vendor selection.
Requirements
- Bachelor’s degree in life sciences, health informatics, computer science, or a related field.
- 10+ years of experience in clinical data management, including sponsor-side vendor oversight.
- Hands-on experience with major EDC platforms, such as Medidata Rave or Veeva CDMS, and external data reconciliation.
- Working knowledge of CDISC (CDASH and SDTM), MedDRA/WHODrug coding, ICH E6(R3), and 21 CFR Part 11.
- Experience taking studies through database lock and supporting a regulatory submission.
- Self-organized, highly motivated, and attentive to detail.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to understand and execute the company’s mission and values.
- High ethical standards and trustworthiness.
- Open mindset when approaching challenges and conflict.
- Ability to think and adapt in a rapidly changing environment.
- Strong time-management and organizational skills.
- Ability to manage multiple projects in a fast-paced environment.
Nice To Haves
- RWE or observational study experience.
Responsibilities
- Lead sponsor review and approval of data management plans, eCRF design, edit check specifications, data review plans, and data transfer agreements.
- Oversee EDC build, participate in user acceptance testing, and approve go-live.
- Monitor CRO data management performance against KPIs, including query aging, data entry timeliness, open discrepancies, and cleaning status.
- Own database lock readiness, including lock checklists, reconciliation sign-off, and sponsor approval to lock.
- Oversee integration and reconciliation of external data, including central lab, IRT, eCOA/ePRO, imaging, and biomarker data, as well as SAE reconciliation with Safety.
- Oversee medical coding using MedDRA and WHODrug in collaboration with Clinical Science and Medical review.
- Partner with study leads and Clinical Science on ongoing clinical data review, listings, and trend detection as part of risk-based quality management.
- Drive consistent data standards across the portfolio, including CDASH collection, CDISC SDTM oversight, and reusable eCRF and edit-check libraries.
- Define data collection for Phase 3b/4, registry, and chart review studies, including abstraction forms, data dictionaries, source data quality checks, and transfer specifications proportionate to study risk.
- Ensure data management TMF artifacts are complete and current, and support audits and inspections related to data handling and computerized system validation.
- Contribute to vendor selection for CROs, EDC, and specialty data vendors.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
