We are seeking an experienced and detail-oriented Manager of IT to lead and support our IT operations and to perform systems administration in a fractional, fully remote role (approximately 20 hours per week). This key position is responsible for ensuring secure, efficient, and compliant IT systems in support of our Contract Research Organization’s (CRO) scientific, operational, and regulatory functions. The ideal candidate will have experience in regulated industries (e.g., pharmaceutical, biotech, medical device), strong technical and leadership capabilities, and demonstrated success managing both internal IT staff and external service providers. The candidate must also have expert-level skills in Microsoft 365 applications, including Outlook, Teams, Word, Excel, and PowerPoint. In addition, this role will be responsible for drafting and maintaining company-wide IT policies, procedures, and guidelines, ensuring they align with regulatory standards and internal operational requirements. ________________________________________ Key Responsibilities: IT Leadership & Oversight: • Lead the IT function in a part-time capacity, ensuring performance, uptime, and compliance. • Manage the relationship with the external IT service provider, including coordination of services, performance oversight, and escalation oversight. • Supervise internal IT support staff, overseeing task delegation, performance, and support quality. • Ensure all internal and outsourced IT functions meet business needs, user expectations, and regulatory standards. Policy & Documentation Management: • Author, update, and maintain IT procedures, SOPs, and guidelines in alignment with company policies, regulatory standards (e.g., GxP, 21 CFR Part 11, HIPAA, GDPR), and industry best practices. • Ensure documentation is audit-ready, well-organized, and consistently reviewed and updated. • Collaborate with the Quality team to maintain alignment between IT practices and quality management systems. Microsoft 365 Administration & Support: • Lead administration and support for Microsoft 365 tools, including Teams, Outlook, Word, Excel, SharePoint, and OneDrive. • Train and support users in best practices, usage efficiency, and security settings within the Microsoft 365 ecosystem. • Manage data governance within Microsoft 365 in conjunction with the MSP. Systems Administration & Access Control: • Serve as the system administrator for key business systems, communication platforms, cloud-based applications, and file storage applications used by the organization. • Manage user access by provisioning, modifying, and revoking user accounts and permissions across systems in accordance with company policies and role-based access control. • Oversee infrastructure components either directly or in coordination with internal staff and the external IT service provider, including cloud services. • Ensure all key business systems accounts are active, number of user seats is managed, MFA enabled, and systems are monitored for performance and security. • Maintain clear records of system changes, access rights, and administrative actions to support audits, inspections, and internal reviews. • Ensure cybersecurity controls are in place and effective, including encryption, firewalls, antivirus, and user access policies. Compliance & Regulatory Alignment: • Ensure IT systems and documentation meet GxP, 21 CFR Part 11, HIPAA, and GDPR requirements. • Support regulatory audits and inspections by preparing and maintaining accurate system documentation, change logs, and vendor oversight records. • Align IT practices with company SOPs, particularly in support of regulated systems, data security, and data integrity. User Support & Enablement: • Oversee internal user support processes, ensuring timely resolution by the IT service provider. • Manage employee onboarding/offboarding processes including account creation, permissions, and IT orientation. • Deliver or coordinate user training on systems, tools, policies, and cybersecurity. ________________________________________ Qualifications: Education: • Bachelor’s degree in Information Technology, Computer Science, or related field; OR equivalent work experience. • Microsoft certification(s) preferred; Other certifications are a plus. Experience: • 7+ years of experience in IT systems administration, with at least 2 years in a managerial or leadership role. • 3+ years of experience working in a regulated industry (e.g., CRO, pharmaceutical, biotechnology, medical device, or another regulated medical environment). • Proven experience managing internal IT staff and external IT service providers. • Hands-on experience writing and maintaining IT policies, procedures, guidelines, and SOPs. Technical Skills: • Advanced proficiency in Microsoft 365 tools and administrative functions (Teams, Outlook, Excel, Word, PowerPoint, etc.). • Deep knowledge of cloud platforms and file share systems. • Strong understanding of IT compliance, audit readiness, and regulatory documentation. Soft Skills: • High attention to detail with a collaborative, problem-solving approach. • Excellent written communication skills, especially for policy writing and documentation. • Strong organizational, leadership, and project management skills. • Self-starter capable of working independently in a remote, part-time capacity.
Keyword: Project Coordinator
Price: $60.0
Vendor Management IT Management Information Technology
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