Senior Manager, Business System Administration
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Job Description
Objective / Purpose:
Support R&D clinical development delivery by serving as the senior business system administration leader and operational owner for assigned clinical and operational data platforms, establishing a consistent administration operating model, access management and controls, study and system release readiness, intake and tiered support, and inspection-ready GxP documentation to enable reliable adoption, high-quality user experience, and continuous improvement across programs.
Accountabilities:
- Own the system administration operating model for supported clinical and operational systems, including standardized ways of working, controls, and continuous improvement to optimize end-user experience and service outcomes.
- Lead the business system administrator team by setting priorities and expectations, coaching performance, building capability/coverage, and ensuring consistent execution across administration, training, and support activities.
- Manage the intake/inbox process end-to-end, including triage, prioritization, SLAs, KPIs, escalation paths, and routine performance reporting to stakeholders with actions to improve timeliness and quality.
- Act as the business system administration leader and technology SME for supported systems, providing guidance on capabilities and standards and ensuring consistent best-practice application across studies/teams and partners.
- Own demand and backlog for administration and support enhancements; partner with Product Team and BSOs to define requirements, plan releases/upgrades, participate in testing/readiness (where applicable), and ensure smooth cutover and stabilization.
- Contribute to vendor governance by participating in routine touchpoints, ensuring adherence to defined processes and deliverables, escalating risks/issues, and driving consistent execution across internal and external stakeholders.
- Accountable for access management, including role implementation, approvals, periodic access reviews/audits, and timely remediation and documentation.
- Oversee role-based training assignments and end-user enablement materials, including maintaining training curricula, supporting development of materials and job aids, and managing knowledge content aligned to process and system changes.
- Collaborate with adoption leads to deliver SET-facing communications and guidance, and establish structured feedback loops to improve usability, adoption, and resolution quality.
- Ensure tiered support and service management, including incident and problem management, escalation coordination, documented outcomes/closure, and root-cause trending with corrective and preventive actions to reduce recurrence.
- Accountable for GxP system administration documentation and evidence (SOPs/WIs, work practices, records), archival and inspection readiness, and representing the function in audits/inspections including coordination of auditor/inspector access as needed.
Education & Competencies (Technical and Behavioral):
- Bachelor’s degree (BS/BA) required in health/life sciences or technology-related field; or commensurate experience.
- Minimum 6 years drug development and pharma/project administration/administrative experience with clinical and operational systems preferred (e.g., EDC, CTMS, eTMF, etc).
- Demonstrated knowledge of SDLC and applicable GxP/ICH/FDA expectations; experience supporting clinical technologies and/or operational data systems
- Strong project management, stakeholder management, and written/verbal communication skills; able to work effectively in a complex matrix/global environment.
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