Lead Clinical Data Management, Clinical Data Management, R&D, Orion Corporation

Lead Clinical Data Management is responsible for leading the execution of clinical data management activities across Phase I–III oncology clinical trials from study startup through database lock and submission readiness. Reporting to the Head of Clinical Data Management, this role ensures the delivery of high-quality, inspection‑ready, and submission‑ready clinical data that support study execution, development decisions, and regulatory submissions. This role can be based in Cambridge (MA) or in Cambridge, UK and reports to the Head of Clinical Data Management. Responsibilities Lead end-to-end clinical data management activities for one or more oncology clinical studies from protocol review through database lock and study closeout. Serve as the primary Data Management representative on cross‑functional study and program teams, ensuring alignment of data management activities with study objectives, timelines, and deliverables. Develop and execute study‑level data management plans and processes that support efficient study conduct, data quality, regulatory compliance, and submission readiness. Lead the design, review, and implementation of eCRFs, database builds, edit checks, derivations, data review plans, and study‑level data management documentation. Lead integration, reconciliation, and review of external data sources including laboratory, imaging, ePRO, genomic, biomarker, and safety data to ensure accuracy, completeness, and consistency. Drive ongoing data review, query management, discrepancy resolution, and risk‑based data quality activities to support timely and accurate study deliverables. Own database lock planning, execution, and closeout activities while ensuring timely delivery of high‑quality, analysis‑ready datasets. Ensure compliance with CDISC standards, ICH‑GCP requirements, applicable regulations, SOPs, and industry best practices. Serve as the Data Management representative on regulatory inspections, audits, due diligence activities, and health authority interactions related to clinical data management. Drive continuous improvement initiatives, standardization efforts, and implementation of scalable data management processes across the portfolio. Evaluate and implement AI‑assisted data review, automated query prioritization, data quality monitoring, and automation capabilities to improve data quality, operational efficiency, and study execution. Contribute to departmental initiatives, process improvements, knowledge sharing, and operational objectives established by the Head of Clinical Data Management. Qualifications Degree in Life Sciences, Data Science, Computer Science, Biostatistics, or a related discipline; advanced degree preferred. 10+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry. Demonstrated experience leading data management activities across multiple clinical development programs. Strong expertise with Medidata Rave EDC, database design, external data integration, database lock processes, and clinical data lifecycle management. Deep knowledge of CDISC standards, including CDASH and SDTM, and their application within global development programs. Experience managing CROs, external vendors, and complex data streams including imaging, laboratory, ePRO, genomic, and biomarker data. Experience supporting health authority submissions, inspections, and audit activities. Experience implementing process improvement, automation, and operational excellence initiatives. Understanding of AI‑assisted data review, automation technologies, and advanced analytics applications within clinical development. Excellent leadership, communication, collaboration, and strategic thinking skills. #J-18808-Ljbffr Orion Pharma