Manager, Clinical Systems and Technology/Business System Owner

Position Summary:
Responsible for assessing, implementing, and maintaining Clinical Systems as the Business System Owner (BSO), partnering with internal cross-functional stakeholders and external suppliers for clinical systems and technology. This role will work closely with Business Process Owners and representatives from Digital Systems Quality Assurance and Computer System Validation to deliver and maintain validated Clinical Systems.

Responsibilities:

• Provides leadership and expertise within the BSO role for clinical trial systems and technology to support organizational business objectives.
• Leads validated implementation of systems and maintains validated state of systems including tracking and managing system releases.
• Participates in the authoring, execution, and approval of validation documentation, including but not limited to: GxP IT System Questionnaire, User Requirements, Validation/Testing Plan, Test Script development and execution, SOP development, and end-user training.
• Maintains the validated state of GxP systems, including assessing system releases for impact, managing change controls for configurations/optimizations of existing systems, and executing testing as required.
• Evaluates industry changes and trends and proactively identifies and offers recommendations for organizational preparation/adoption of future capabilities related to trial technology and systems.
• Oversees/supports supplier partnerships and acts as internal project manager for clinical systems and technology-related activities to ensure deliverables stay on track.
• Assists/manages contracting activities including establishing initial Scope of Work (SOW) and Change Orders, as applicable.
• Acts as primary business change agent within Development Operations to ensure adoption of new capabilities and business processes related to clinical systems and technology.
• Provides support to study teams and works with supplier(s) in day-to-day management including resolution of issues and escalation, as appropriate.
• Manages system access for study team members.

Position Requirements:

• Bachelor’s degree is required.
• Minimum of 6 years’ experience working in clinical research setting with a Sponsor/CRO company is required.
• Experience working with GxP validated systems (on the system administration or Business System Owner capacities).
• Experience in clinical trial conduct in multiple phases of development is preferred.
• Strong project management skills and demonstrated flexibility and agility working within a multi-functional, global matrix.
• Must have excellent communication skills (verbal and written, including presentation/training skills), and good interpersonal/group skills.
• Must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
• Must have experience with organizational change management, introducing new systems to Users and ensuring they are supported throughout system adoption.

Travel:
Up to 15%, domestic and international may be required.