IT Manager

The IT Manager – Clinical Trials is responsible for overseeing the design, implementation, security, and ongoing support of IT systems that enable clinical trial operations. This role manages cloud-based infrastructure across Microsoft Azure and Google Cloud Platform (GCP), supports validated clinical systems, ensures regulatory compliance (GxP, HIPAA, 21 CFR Part 11), and partners closely with Clinical Operations, Data Management, and Engineering teams. The role combines people leadership, cloud architecture oversight, vendor management, and compliance ownership in a regulated clinical research environment.

DUTIES & RESPONSIBILITIES

IT Operations & Service Management

• Lead IT operations including incident management, change management, and problem resolution
• Define and maintain IT policies, SOPs, and runbooks
• Manage SLAs with internal teams and external vendors

Cloud & Infrastructure Management

• Own and manage cloud infrastructure across Azure and GCP, including compute, networking, storage, databases, and security services
• Ensure high availability, scalability, disaster recovery, and cost optimization of cloud environments
• Oversee hybrid and multi-cloud architectures supporting clinical trial platforms
• Manage identity and access using Azure AD / IAM, role-based access control (RBAC), and least-privilege principles
• Support end-user IT needs related to clinical systems and secure access

Clinical Systems & Applications

• Support IT systems used in clinical trials (e.g., CTMS, eTMF, EDC, patient engagement platforms, AI/telephony systems)
• Partner with engineering teams supporting custom platforms (e.g., patient management, communications, integrations)
• Ensure validated system lifecycle management (CSV/CSA) for GxP systems
• Oversee system integrations, APIs, and data flows between internal platforms and third-party SaaS Vendors

Security, Compliance & Risk

• Ensure compliance with HIPAA, GDPR, GxP, 21 CFR Part 11, SOC 2, and internal security policies
• Lead audit readiness, vendor assessments, and security reviews
• Implement monitoring, logging, incident response, and vulnerability management
• Own data protection strategies including encryption, backup, retention, and access auditing

Leadership & Collaboration

• Manage and mentor IT staff and/or contractors
• Act as a trusted IT partner to Clinical Operations, QA, Compliance, Product, and Engineering teams
• Translate clinical and business requirements into secure, scalable technical solutions
• Participate in technology roadmap planning and platform modernization initiatives

KNOWLEDGE & EXPERIENCE

Education & Experience

• Bachelor’s degree in Information Technology, Computer Science, or related field (or equivalent experience)
• 7+ years of progressive IT experience, including 3+ years in a leadership or managerial role
• Direct experience supporting clinical trials, life sciences, healthcare, or regulated environments

Credentials:

• Associate Google Workspace Administrator (preferred)

Knowledge and Skills:

• Strong hands-on and architectural experience with Microsoft Azure
• Working knowledge of Google Cloud Platform (GCP)
• Experience with cloud databases (SQL, NoSQL), networking, and API-based systems
• Familiarity with DevOps, CI/CD, and infrastructure-as-code concepts
• Understanding of system validation and computerized system assurance (CSV/CSA)