NJ based Clinical Research Org. seeks a strategic,operationally minded, and hands-on Director of IT to lead and evolve ourinternal technology function across both government and commercial programs.The ideal candidate will be an experienced IT leader who can synthesizetechnical complexity into clear, actionable plans that align with clinical andbusiness goals.
Thisis not a "heads-down" role—it's a leadership position that seeks strategic vision, team oversight, and active engagement in execution. The IT department isundergoing transformation. This is a unique opportunity where you’llbe responsible for restructuring,mentoring, and rebuilding a high-performing IT organization that can supportour mission-critical clinical systems and digital reshaping initiatives
Key Responsibilities
Lead a diverse internal IT team across five core functions, maintaining visibility into each at a strategic (2,000-ft) level
Evaluate and restructure the current IT org chart — identify gaps, reassign roles, and optimize FTEs vs. contractors
Build strong partnerships with clinical and operational teams to ensure IT supports user needs
Guide the migration of systems and databases (Oracle, .NET, Git, etc.) to the cloud and recommend optimal platforms (e.g., evaluating Aurora vs. Oracle)
Oversee the development and validation of programs using technologies such as C#, .NET, Oracle, MedidataRave, and SQL for data extraction, transformation, and loading (ETL).
Direct the creation of high-quality graphical reports and dashboards using BusinessIntelligence tools, providing actionable insights for clinical trial progress and outcomes.
Direct application development for both internal and external stakeholders, includingClinical Trial Management Systems (CTMS), IWRS/IVRS platforms, and reporting systems (Power BI, RAVE)
Support CFR Part 11/GxP-compliant systems, focusing on documentation, validation, and specifications
Collaborate on digital transformation and modernization of legacy systems — including redeployment of government-developed tools into commercial use
Ensure proper IT participation in every new client setup, including Medidata and internal systems integration
Quantify, document, and communicate IT’s alignment with business goals
Participate in strategic planning, budgeting, and vendor oversight to ensure ROI and performance from external providers
Qualifications
BS degree
10+ years of progressive IT experience, with at least 3 years in a Director or equivalent leadership role
Proven success managing cross-functional IT teams (development, infrastructure, validation, etc.)
Experience in biotech, life sciences, clinical research, healthcare, or regulated environments
In-depth understanding of clinical trial phases, data flow, and regulatory requirements (e.g., CDISC standards, 21 CFR Part 11).
Strategic thinker with operational execution skills — able to go from 50,000 feet to ground level as needed
Track record of change management, team restructuring, and mentoring talent
Strong communication and collaboration skills with technical and non-technical stakeholders
Background in hybrid IT environments, ideally across government and commercial projects
Numbers & Facts
Location
Princeton, New Jersey
Skills
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Budget Managementunmatched
Change Managementunmatched
Clinical Data Interchange Standards Consortium (CDISC)unmatched
Clinical Information Systemsunmatched
Clinical Researchunmatched
Clinical Trialunmatched
Cloud Computingunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Database Extract Transform and Load (ETL)unmatched
Gitunmatched
Governmentunmatched
GxPunmatched
Healthcareunmatched
Information Technology & Information Systemsunmatched
Leadershipunmatched
Mentoringunmatched
Microsoft .NETunmatched
Microsoft C# (C Sharp)unmatched
Operational Strategyunmatched
Oracleunmatched
Power BIunmatched
Regulatory Requirementsunmatched
Reporting Dashboardsunmatched
Return on Investment (ROI)unmatched
SAP BusinessObjects Business Intelligence (BI)unmatched
SQL (Structured Query Language)unmatched
Software Developmentunmatched
Strategic Planningunmatched
System Integration (SI)unmatched
System Migrationunmatched
Team Lead/Managerunmatched
Team Playerunmatched
Technical Leadershipunmatched
Technical Supportunmatched
Validation Documentationunmatched
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