Manager, Clinical Operations Business Systems

The Manager, Clinical Operations Business Systems sits within the Development Operations Organization and will provide support to key Clinical Trial Management Systems (CTMS) required to manage the execution of clinical trials. The role successfully integrates the CTMS Ecosystem capabilities and cross-functional alignment with R&D functions to drive effective system implementations and ongoing maintenance. Requires frequent interaction with Sr. Leadership and cross-functional management to provide system health summaries, including defect management, user adoption, enhancement/release planning, and related compliance activities.

• Business Subject Matter Expert of key clinical trial management systems in partnership with Business Technology Solutions (BTS) to support the business in the conduct of clinical trials. Provide input into all business project deliverables, including strategic decision-making, stakeholder management, schedule development, budget preparation, and communication. Ensure on-time and within budget implementation.
• Anticipate emerging technology needs; adjust and revise strategy and action plans accordingly.
• Ensure system support training materials are kept up-to-date.
• Support the rollouts of cross-functional systems and effectively manage the change request process, monitor end user adoption, and support the management of future system releases/enhancements, eliminating any duplications of data fields.
• Review system change requests to evaluate if a change is needed or re-education of the business process
• Support the business in developing user requirements and testing for any new system enhancements
• Assume primary business owner responsibility for the CTMS, including review and approval of SLC deliverables, business risk assessment for the system and its data, records retention and disposition of data, application of legal hold orders, resolution of compliance or system data integrity issues, and management of change requests.
• Represent Dev Ops in regional forums and on cross-functional teams related to shared technologies between Medical and R&D.
• Maintain knowledge of current R&D systems (i.e. Tesla, Veeva Modules, AIX, etc.) and alignment to existing business processes.
• Support the business in ensuring proper ongoing use of the system, leveraging metrics and BTS information to system use behavior is as intended.

• Bachelors Degree in a scientific or business field preferred.
• 6 years of experience in pharmaceutical with knowledge of clinical trials, clinical trials process and technology, healthcare, or regulated industry with experience in project management or business technology support.
• Operations experience working in a complex and matrix environment. Experience using clinical trial systems preferred.