Senior Principal Risk-Based Quality Management Data Monitor

Responsibilities Partner with cross‑functional teams to identify critical data and processes (CDPs) and associated study risks Contribute significantly to the development and maintenance of the study‑specific Risk Assessment Categorization Tool (RACT) or equivalent by providing a clinical data management focused perspective Prioritize risks and signals based on patient safety impact, data integrity, severity, likelihood, and detectability Conduct proactive, ongoing data reviews using RBQM dashboards and analytics tools Ensure timely escalation and follow up on any signals or anomalies Review and validate data across EDC, safety, and other clinical systems to ensure consistency and quality Oversee data cleaning timelines and ensure adherence to risk mitigation plans Document and communicate findings clearly and effectively to study teams Trigger and/or support Corrective and Preventive Actions (CAPA) Ensure alignment with ICH‑GCP, FDA/EMA regulations, and internal SOPs Support audit and inspection readiness related to RBQM and centralized monitoring Contribute to and/or lead process enhancements, technology upgrades, and RBQM best practices Provide training, guidance, and mentorship on RBQM concepts to study teams Qualifications 7+ years of experience in clinical data management, clinical operations or academia with strong scientific knowledge in at least one therapeutic area within the Biogen portfolio RBQM‑focused roles within pharma or CRO settings Hands‑on experience with centralized monitoring tools (RBQM platforms/dashboards), KRIs, QTLs, or similar RBQM methodologies Proficiency with EDC systems and data visualization tools High attention to detail, including proven ability to manage multiple, competing priorities Experience supporting audits/inspections Understanding of clinical data flow, study endpoints, and regulatory requirements Strong analytical and critical‑thinking abilities Excellent communication and stakeholder management skills Ability to adapt and thrive in a dynamic, cross‑functional environment Risk‑based thinking & structured problem‑solving Data‑driven decision‑making Collaborative teamwork across clinical and operational functions Deep understanding of drug development and biopharmaceutical industry required Fluent English (oral and written) Demonstrated ability to identify data trends, signals, outliers, and risk indicators using listings, visualizations, metrics, and analytics tools Strong knowledge of GCP, ICH E6(R2)/E6(R3), regulatory expectations, and industry data quality best practices Demonstrated problem‑solving skills with a continuous improvement mindset and enthusiasm for scientific data excellence #J-18808-Ljbffr Jobtailor