Manager, Clinical Operations Business Systems
The Manager, Clinical Operations Business Systems sits within Development Operations 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 the clinical trial management system TESLA, involved in the creation of system status reports and tracking of items (enhancements, change requests, dashboards, and integrations) in partnership with Business Technology Solutions (BTS).
- 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.
- Anticipate emerging technology needs; adjust and revise strategy and action plans accordingly Ensure system support training materials are kept up to date.
- Support the roll-outs 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 duplication 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 Vault, AIX, PBR, etc.) and alignment to existing business processes.
- Support the business in ensuring proper ongoing use of the system, leveraging metrics and IR/BSOS 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 TESLA preferred