JOB SUMMARY

The Sr Manager, IT Enterprise Solutions, will support and manage Clinilabs’ clinical operations enterprise GxP Systems and business applications. This position has primary responsibility for SaaS and AWS hosted clinical systems to include Veeva eTMF/CTMS/eISF modules, SAS Analytics, EDC, study participant recruitment systems, and electronic data exchange solutions.

RESPONSIBILITIES

• Designated IT System Owner for Global Clinical Operations Enterprise Solutions. 
• Develop standard operating procedures (SOPs), work instructions (WIs), and computerized systems validation deliverables to include URS, UAT, Risk Assessments, System and User Access Administration documents.   
• Provide audit support as an SME supporting IT policies and regulatory requirements for sponsors and regulatory authorities.  
• Participate in the development of Clinilabs IT data governance policies & procedures.  
• Proactively maintain IT compliance and data integrity across the Clinilabs GxP IT Portfolio, identifying risks and proactive initiatives.  
• Participate in the review of completed software quality audit questionnaires, including software development methodology, testing standards, configuration management, application patching, and security assessments. 
• Conduct system periodic reviews and release management.   
• Create project plans for systems implementations and upgrades. 
• Other duties as required or assigned. 

TRAVEL 

Remote, but expected to make occasional site visits to our Manhattan and Eatontown, NJ locations.

REQUIRED EDUCATION, KNOWLEDGE, SKILLS, AND ABILITIES

• This position of Sr Manager, IT Enterprise Systems requires a bachelor’s degree in a technical field such as Computer Science, Engineering, Chemistry/Biology. Extensive experience instead of a degree will be considered. 
• 7+ years of experience working in IT with an emphasis on clinical research solutions, including eTMF, CTMS, EDC, participant enrollment, and Enterprise Systems. 
• Strong understanding of FDA 21 CFR Part 11, 210, and 211, ICH Q8/9/10, ICH R3, and EU Annex 11. 
• Working knowledge of AWS network and computerized solutions.   
• Good communication, presentation, negotiation, and interpersonal skills. 
• Strong candidates will have project and vendor management expertise.  
• Experience in a CRO or other life sciences environment is required.