Manager, Biospecimen Reporting and Automation

Responsibilities

• 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 RD 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.

Competencies

• Advanced SQL querying and data modeling capability.
• Proficiency in Python or similar programming language.
• BI platform expertise (Power BI, Tableau, equivalent).
• Strong understanding of relational data structures and interface dependencies.
• Knowledge of validation frameworks in regulated environments.
• Ability to translate operational processes into scalable automation.
• Data visualization and executive-level insight synthesis.
• Continuous improvement and digital-first mindset.

Qualifications

The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.

Minimum Requirements

Doctorate degree

OR

Masters degree 3 years of experience in supplier management at sponsor or supplier leadership at the vendor

OR

Bachelors degree 5 years of experience in supplier management at sponsor or supplier leadership at the vendor

OR

Associates degree and 10 years of experience in supplier management at sponsor or supplier leadership at the vendor

AND

• 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

Preferred Requirements

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