Manager, Biospecimen Reporting and Automation

• Define and maintain standards for automated reporting, dashboards, and validation practices
• Oversee development and maintenance of Appendix I reports and other regulated analytics deliverables
• Review and approve dashboards, scripts, and reporting templates prior to production release
• Ensure compliance with data governance, validation logic, and version control requirements
• Serve as escalation point for complex automation failures, data discrepancies, or reporting risks
• Partner with Data Management, Clinical Operations, IT, and Quality to align analytics outputs with business and regulatory needs
• Deliver or oversee delivery of monthly KPI and performance summaries to R&D Ops leadership
• Drive continuous improvement by identifying opportunities to expand automation and reduce manual reporting burden
• Support inspection readiness by ensuring documentation, validation, and traceability of analytics tools
• Accountable for creation of automation and maintenance of standard reporting suite
• Accountable for development of dashboards (SLA adherence, discrepancy trends, shipment health, pending analysis, study health)
• Accountable for backend query development (SQL) and script automation (Python or equivalent)
• Accountable for validation and version control of reporting logic and templates
• Accountable for Back Office Study Health Pack production (KPIs, exceptions, action recommendations)
• Accountable for cross-TA KPI insights and QBR-ready performance analytics
• Accountable for automation change control lifecycle (requirements → build → test → validation → release → monitoring)
• Accountable for reducing manual data pulls and improving data reliability
• Accountable for master reporting governance and data lineage traceability

• Doctorate degree
• OR Master’s degree & 3 years of experience in supplier management at sponsor or supplier leadership at the vendor
• OR Bachelor’s degree & 5 years of experience in supplier management at sponsor or supplier leadership at the vendor
• OR Associate’s degree and 10 years of experience in supplier management at sponsor or supplier leadership at the vendor
• Strong project management experience
• Fluency in English, both in written and oral communication
• Excellent user of Office Programs such as Excel, Word, Power point
• Scientific or drug development technical expertise supporting Research, Development, Medical, Global Regulatory, Global Safety or Knowledge Management

• 7 years work experience in life sciences field, including 4 years of biopharmaceutical R&D experience
• Functional experience managing oversight of R&D suppliers (CROs, specialty labs, imaging suppliers, etc.)
• Experience working in a global, matrix organization

Reasonable accommodation for individuals with disabilities