Job Summary:
Associate Director, Data Management oversees startup and execution of clinical trials with a CRO or in-house to ensure data quality and integrity. Provides data management clinical development program leadership and delivers complete, accurate, high-quality, regulatory-compliant data for publications and regulatory submissions.
Responsibilities:
- Lead data management deliverables and timelines; ensure inspection readiness/compliance.
- Lead DM subject-matter expertise in study management meetings; participate in audits/regulatory inspections.
- Serve as Lead CDM with daily CRO/vendor oversight for DM execution.
- Perform ongoing clinical data reviews to resolve discrepancies/trends; review protocol deviations, coding, and database UAT.
- Review vendor/department documents; cross-functionally assess needs.
- Plan database locks and multiple deliverables; contribute to SOPs and study protocols.
- Guide clinical data management personnel; set up/maintain/archive DM documentation (e.g., Data Management Plan, CRF Completion Guidelines).
- Monitor timelines/budget; work with minimal supervision.
Education/Experience (Required):
- Bachelorβs degree in life science/pharmacy or related field.
- 8+ years direct Data Management experience.
Skills/Experience (Required/Preferred):
- Clinical trial vendor management/integration; CRO experience preferred.
- CDASH/SDTM terminology; strong integration experience across data platforms.
- ICH and GCP understanding; MedDRA/WHODrug dictionary coding and vendor reconciliation.
- EDC systems experience (preferred Medidata RAVE); integrations using EDC, IRT, ePRO, external labs.
- AI models for data collection/quality preferred; travel as needed (~10%); not 100% remote.
Benefits/Compensation:
- Premium health/financial/work-life/well-being offerings, life insurance, disability, retirement with match, generous PTO.
- Target base pay range: $150,000β$195,000; cash + short/long-term incentives.
Application instructions:
- Apply on an ongoing basis until selected.