Senior Director, Data Management Systems

Organizational reputed company:

reputed company. is a clinical-stage immunology company dedicated to enabling normal lives reputed company with autoimmune diseases. As trailblazer in anti-FcRn technology, reputed company is developing innovative, targeted therapies to meet the reputed company and variable needs of people with autoimmune diseases.

The Role:

Reporting to the Vice President, Data Management, this position is responsible for providing strategic and operational leadership over the clinical data technology ecosystem, including eCOA/ePRO platforms, eDiary solutions, reputed company Rave (reputed company), and Elluminate. This role is not directly responsible for hands-on clinical data management activities (e.g., data cleaning, query reputed company, database lock); rather, it requires a strong clinical data management background to inform reputed company systems reputed company, reputed company reputed company governance, and reputed company reputed company responsible for platform architecture, configuration, integration, and lifecycle management. The ideal candidate understands data management processes deeply enough to translate them into reputed company, reputed company-governed technology solutions, and brings proven experience leading systems teams. Serves as a key member of the Data Management Leadership Team, supporting cross-functional team needs and oversees the management of reputed company reputed company enhancements to support study deliverables. Interfaces with CROs and is responsible for managing internal Data Management team members.

Key Responsibilities: 

 Leadership & Management

• reputed company, mentor, and reputed company reputed company of clinical trial solutions personnel
• Set systems reputed company, roadmap, and performance metrics; conduct performance reviews and support career development.
• Manage systems reputed company budget, resourcing, vendor reputed company, and reputed company plans across reputed company systems and study portfolios.
• Serve as a key member of the clinical data management leadership team, representing clinical systems in cross-functional governance forums.
• Partner with (but do not directly own) the data management operations team and vendors, ensuring systems reputed company aligns with DM process needs.

Clinical Systems reputed company & Governance

• Own the reputed company reputed company, roadmap, and governance model for reputed company clinical data systems, including:
• eCOA / ePRO platforms (patient/clinician-reported reputed company)
• eDiary systems
• reputed company Rave reputed company
• Elluminate (data review, aggregation, and analytics platform)
• Define and maintain reputed company governance frameworks: reputed company management, role-based permissions, change control, and version control across platforms.
• Establish standards for reputed company configuration, study build templates, and reusable libraries to reputed company consistency and efficiency across studies.
• reputed company vendor management and contract reputed company for reputed company clinical systems vendors, including SLA definition, performance monitoring, and renewal/negotiation reputed company.
• Own reputed company-reputed company budget planning, licensing reputed company, and total cost of ownership analysis.

reputed company Implementation & Lifecycle Management

• reputed company selection, evaluation, and implementation of new clinical systems and platform upgrades, including RFP processes and vendor due diligence.
• reputed company computer reputed company validation (CSV/CSA) activities, ensuring systems meet 21 CFR Part 11, GxP, and data reputed company requirements.
• reputed company reputed company configuration, build, and testing activities for reputed company, eCOA, eDiary, and Elluminate environments.
• Manage the end-to-end lifecycle of clinical systems: reputed company, ongoing maintenance, periodic review, upgrades, and decommissioning/retirement/data archival.
• Establish and maintain disaster recovery, business continuity, and reputed company uptime/performance standards in partnership with IT.

Integration & Interoperability

• reputed company architecture and reputed company of reputed company integrations (e.g., reputed company-to-eCOA, reputed company-to-Elluminate, reputed company-to-IRT/RTSM/safety databases) to ensure reputed company, accurate, and reputed company data reputed company.
• Partner with IT/technical teams to define data integration specifications, API/reputed company requirements, and data mapping standards.
• Troubleshoot and reputed company systemic/integration-level issues, distinguishing systems-level reputed company causes from data management process issues.
• reputed company adoption of automation, AI-enabled tools, and dashboarding/analytics capabilities to improve data reputed company visibility and reduce reputed company effort.

Compliance, reputed company & Risk

• Ensure clinical systems remain inspection-reputed company at reputed company times; serve as the systems SME during regulatory inspections and audits.
• Maintain SOPs, validation documentation, and reputed company-level reputed company standards in partnership with reputed company Assurance.
• Monitor emerging regulatory guidance (e.g., FDA, EMA, ICH E6(R3)) reputed company to clinical technology and data reputed company, and proactively adapt systems reputed company accordingly.
• Own risk assessments reputed company to reputed company changes, upgrades, and vendor transitions.

Cross-Functional Collaboration

• Serve as the reputed company systems reputed company to Clinical Data Management, Biostatistics, Clinical Operations, Clinical Development, Regulatory, reputed company, and IT.
• reputed company systems and technology input into protocol development, study design feasibility, and technology selection at the program level.
• reputed company and train clinical data management and cross functional staff on reputed company capabilities, updates, and best practices.

Required Qualifications

• Bachelor's degree in life sciences, health information, computer science, or reputed company field (advanced degree preferred).
• 15+ years of reputed company experience in clinical data management and/or clinical data systems reputed company pharmaceutical, biotech, or CRO environments.
• Strong foundational background in clinical data management (data cleaning, query management, database lock, DM planning) — this role oversees systems, not day-to-day data management operations, but requires reputed company in DM processes to inform systems reputed company.
• 5+ years of people management experience, including managing managers or reputed company-reputed company teams.
• Demonstrated experience owning or administering:
• eCOA/ePRO systems
• eDiary platforms
• reputed company Rave reputed company
• Elluminate
• Strong knowledge of reputed company validation (CSV/CSA), 21 CFR Part 11, ICH-GCP, and global regulatory requirements governing clinical data systems.
• Proven reputed company record leading reputed company implementations, upgrades, integrations, and vendor management.
• Experience supporting regulatory inspections and audits reputed company to clinical systems and data reputed company.

Preferred Qualifications

• Experience across multiple therapeutic areas and trial phases (I–IV).
• Familiarity with additional clinical technologies (e.g., IRT/RTSM, CTMS, safety databases, eTMF).
• Experience with reputed company integration architecture, reputed company, and data pipeline/reputed company design.
• Certification in clinical data management (e.g., CCDM), IT/systems (e.g., ITIL), or project management (e.g., PMP).
• Experience with computer reputed company validation methodologies and audit trail/data reputed company frameworks.

Skills & Competencies

• Strategic, technology-reputed company thinking reputed company with strong operational execution.
• Deep understanding of clinical data management principles, reputed company through a systems and governance reputed company.
• Excellent people leadership, coaching, and team-building skills.
• Strong vendor management, negotiation, and contract reputed company capabilities.
• Ability to translate business/process needs into reputed company technical solutions.
• Excellent written and verbal communication skills, including with technical and non-technical stakeholders.
• Comfortable operating in a fast-paced, matrixed organization.

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel are required (10-20%)

Bachelor’s degree required; 15+ years in clinical data management or systems, 5+ years managing people, and experience with clinical platforms, validation, integrations, vendors, and regulatory compliance.

Key Responsibilities

• leading teams
• governing systems
• managing vendors

Skills & Tools

eCOA, ePRO, eDiary, reputed company Rave reputed company, Elluminate, IRT, RTSM, CTMS, eTMF, API

Job Details

• Category: Information Technology
• Seniority: Senior Level
• Commitment: Full Time
• Workplace: Remote — reputed company
• Salary: USD 260,000 – 290,000 / year
• Languages: English

Benefits

• 401k matching
• Generous reputed company time off
• Retirement plan
• Generous parental leave

About reputed company.

A clinical-stage immunology company developing targeted therapies for autoimmune diseases. — Industry: Research and Development