IT Business Systems Manager – Safety, Clinical Technology Platforms

Position Summary:

 

The IT Business Systems Manager for Safety, Clinical Technology Platforms will responsible for IT GxP / CSV oversight of Apellis technology vendors including but not exclusive to IRT/RTSM, EDC, ePRO/eCOA, Safety/Pharmacovigilance, ensuring that IT GXP best practices are being followed by various technology vendors and managed service support teams. The technical oversight of the GxP SaaS (software as a service) technology solutions will enable each business/functional areas to focus on their business functional area efforts to collect and analyze patient/drug/safety data in compliance with global health authority regulations.

This position will be the IT Lead working with Quality Validation and functional area business teams to ensure IT SDLC and CSV best practices are being followed and documented by the technology vendors. This position will complement the business/functional areas who are responsible for study/drug specific testing, support and documentation details (e.g. within EDC Technology Platforms, the clinical data management team defines, tests and documents study specific details).

This position will be accountable as the IT GxP System Owner for the specified technology platforms and would be called upon to provide evidence of computer system validation and compliance in the case of an audit or inspection. This position will participate in CSV System Periodic Reviews and ensure vendor technology platform feature releases are reviewed accordingly for Apellis usage.

A strong understanding and working knowledge of Good Clinical & PV Practices and Health Authority regulations are required, including ICH E6 (R3).

Location:  Hybrid Waltham, MA 

Key Responsibilities Include:

 

• Represents IT in collaboration with Quality Validation and Business System Owner determine Computer System Validation (CSV) impact and requirements.
• IT Computer System Validation activities includes implementation, system release management, and overall support and system change management. GxP CSV System documentation may include: System Impact Assessments, Plan(s), Requirements/Specifications, Change Controls, Test Scripts (IQ/OQ/PQ/UAT), Data Migration, Traceability Matrix, Summary Report(s).
• Identifies and troubleshoots technical and system/process issues to resolution.
• Provides IT support, including vendor operational and maintenance and oversight to the vendor’s SLAs for contracted managed services and products.
• Prioritize activities and solutions in alignment with overall corporate/business strategies. Review, analyze and evaluate business systems and user needs. Responsible for business systems consulting, project planning, prioritization, and implementation of deliverables, including implementations and operations. Ensures documentation of process and system, functional and business requirements, and objectives for technology initiatives.
• IT Technical SME for system activities for system/process enhancements and integration projects. Coordinates support activities across vendor(s) for support and maintenance and ensures the proper delivery of services.

Experience:

• Degree in computer science, technology, operations, or related disciplines preferred.
• 5-7+ years pharmaceutical/biotech required
• Experience working in a GxP regulated environment;
• Excellent knowledge of 21 CFR Part 11/Annex 11 compliance and Computer System Validation (CSV) and Computer System Assurance (CSA), and IT SLDC best practices
• Project management experience, including requirements gathering and documentation, vendor selection, implementation, and change management
• Experience as a business analyst, including identification of non-technical business requirements and translating specifications into solution designs
• Experience supporting outsourced partner/vendor organizations.

Skills, Knowledge & Abilities: 

 

• Must be able to effectively prioritize and plan; must have the ability to address multiple projects and adapt to changing priorities.
• Ability to handle multiple tasks simultaneously effectively and efficiently with precision and adapt to changes in responsibilities and workloads in a fast-paced, changing environment
• Self-motivated and passionate to learn and adopt new technology and nimble, pragmatic methodologies. Must be able deal with ambiguity, work through issues with agility but without compromise to best practice processes and documentation.
• Exceptional organizational skills, attention to detail and follow through.
• Team-oriented and generous in sharing knowledge and enabling others. Ability to lead change using positive and collaborative methods
• Strong co