Senior Director, Data Management Systems

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic and operational oversight for the clinical data technology ecosystem.

• Lead, mentor, and develop a team specializing in clinical trial solutions.

• Establish systems strategy, roadmap, and performance metrics; conduct performance evaluations and facilitate career growth.

• Manage budget, resources, vendor contracts, and staffing plans related to systems across multiple studies.

• Represent clinical systems in cross-functional governance meetings.

• Own the enterprise strategy, roadmap, and governance for eCOA/ePRO platforms, eDiary systems, Medidata Rave EDC, and Elluminate.

• Define governance frameworks governing access management, role-based permissions, change control, and versioning.

• Set standards for system configuration, study build templates, and reusable libraries.

• Oversee vendor management, contract management, SLA definition, performance monitoring, and renewal/negotiation strategies.

• Lead the selection, evaluation, implementation, and upgrades of clinical systems, including RFPs and vendor due diligence.

• Supervise computer system validation activities and ensure adherence to 21 CFR Part 11, GxP, and data integrity standards.

• Direct system configuration, build, and testing for EDC, eCOA, eDiary, and Elluminate environments.

• Manage the entire clinical systems lifecycle, including onboarding, maintenance, reviews, upgrades, retirement, and data archiving.

• Establish disaster recovery, business continuity, and uptime/performance standards in collaboration with IT.

• Lead the architecture and oversight of integrations among clinical systems.

• Define integration specifications, API/interface requirements, and data mapping standards with technical teams.

• Diagnose systemic and integration-level issues.

• Promote automation, AI-enabled tools, and analytics/dashboarding to enhance data visibility and minimize manual effort.

• Ensure clinical systems are inspection-ready and act as the systems SME during regulatory inspections and audits.

• Maintain SOPs, validation documentation, and system-level quality standards in partnership with Quality Assurance.

• Monitor FDA, EMA, and ICH E6(R3) guidelines and adjust systems strategy accordingly.

• Conduct risk assessments for system changes, upgrades, and vendor transitions.

• Collaborate with Clinical Data Management, Biostatistics, Clinical Operations, Clinical Development, Regulatory, Quality, and IT.

• Provide input on systems and technology for protocol development, study design feasibility, and technology selection.

• Train and educate staff on system functionalities, updates, and best practices.

• Report directly to the Vice President of Data Management.

• Interface with CROs and oversee internal Data Management team members.

⛳️ Requirements

• Bachelor's degree in life sciences, health information, computer science, or a related field.

• 15+ years of progressive experience in clinical data management and/or clinical data systems within pharmaceutical, biotech, or CRO settings.

• Solid foundational knowledge in clinical data management, including data cleaning, query management, database lock, and DM planning.

• 5+ years of experience managing personnel, including oversight of managers or system-focused teams.

• Proven experience in owning or administering eCOA/ePRO systems, eDiary platforms, Medidata Rave EDC, and Elluminate.

• Strong understanding of system validation (CSV/CSA), 21 CFR Part 11, ICH-GCP, and global regulatory standards for clinical data systems.

• Demonstrated success in leading system implementations, upgrades, integrations, and vendor management.

• Experience supporting regulatory inspections and audits related to clinical systems and data integrity.

• Experience across multiple therapeutic areas and trial phases (I–IV) is preferred.

• Familiarity with additional clinical technologies such as IRT/RTSM, CTMS, safety databases, and eTMF is preferred.

• Experience with system integration architecture, APIs, and data pipeline/interface design is preferred.

• Certification in clinical data management, IT/systems, or project management is preferred.

• Familiarity with computer system validation methodologies and audit trail/data integrity frameworks is preferred.

• Strategic and technology-forward thinking paired with strong operational execution skills.

• Comprehensive understanding of clinical data management principles applied through a systems and governance perspective.

• Strong vendor management, negotiation, and contract oversight skills.

• Ability to translate business and process requirements into scalable technical solutions.

• Comfortable working in a dynamic, matrixed organization.

🏝️ Benefits

• Equity and other forms of compensation may be part of a comprehensive compensation package.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• 401(k) plan.

• Unlimited paid time off.

• Parental leave.

• Opportunities for domestic or international travel (10–20%).