Senior Clinical Data Manager, Clinical Data Management, R&D, Orion Corporation

Senior Clinical Data Manager, Clinical Data Management, R&D, Orion Corporation Join a growing oncology-focused Data Sciences function and serve as the data management lead for oncology clinical trials, overseeing all data management activities from study startup through database lock and submission readiness. This role plays a critical part in ensuring the collection, integration, review, and delivery of high-quality clinical data that support study objectives, regulatory submissions, and data-driven decision‑making. The Senior Clinical Data Manager works closely with Clinical Operations, Biostatistics, Statistical Programming, Pharmacovigilance, Regulatory Affairs, CRO partners, and external vendors to provide leadership for clinical data management processes, external data integration, data quality oversight, and operational execution across Phase I–III oncology clinical studies. Key Responsibilities Lead all clinical data management activities for one or more oncology clinical studies from protocol development through database lock and study closeout. Serve as the primary Data Management representative on cross‑functional study teams and act as the main point of contact for data management‑related activities. Lead the design, review, and implementation of eCRFs, database builds, edit checks, derivations, and data validation rules in alignment with study protocols and regulatory requirements. Lead the integration and reconciliation of external data sources including laboratory, imaging, safety, ePRO, genomics, biomarker, and other vendor datasets. Develop and maintain Data Management Plans, Data Transfer Agreements (DTAs), data specifications, reconciliation plans, and study‑level documentation. Responsible for query management, discrepancy resolution, medical coding (MedDRA, WHODrug), and SAE/PV reconciliation. Drive database lock planning and execution to ensure timely delivery of high-quality, submission‑ready datasets. Ensure compliance with CDISC standards (CDASH and SDTM), ICH‑GCP requirements, SOPs, and applicable regulatory guidance. Support regulatory submissions, inspection readiness activities, audits, and health authority requests. Identify opportunities to improve data quality, process efficiency, and operational scalability through automation and standardization initiatives. Partner with cross‑functional stakeholders to evaluate AI‑enabled solutions that support automated data review, query prioritization, risk identification, and operational efficiency. This role can be based in Cambridge (MA) or Cambridge, UK and reports to the Head of Clinical Data Management. Qualifications Degree in Life Sciences, Data Science, Biostatistics, Computer Science, or a related discipline. 5+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry, oncology preferred. Demonstrated experience serving as a lead data manager for Phase I–III clinical studies. Strong expertise with Medidata Rave EDC, database design, eCRF development, edit checks, and clinical data review. Experience managing external vendor data and complex data streams, including imaging, genomics, biomarker, laboratory, and ePRO data. Strong knowledge of CDISC standards, including CDASH and SDTM. Deep understanding of ICH‑GCP requirements, clinical trial processes, and regulatory expectations. Experience supporting database lock, submission readiness, inspections, and audit activities. Strong analytical, problem‑solving, communication, and stakeholder management skills. Interest in emerging technologies, including AI‑assisted data review, automation, and advanced analytics applied to clinical development. Experience with visualization, automation platforms, or AI‑enabled data quality solutions is preferred. The expected annual salary range for this position is USD 80,000–150,000 for U.S.-based candidates, depending on skills, experience, and job‑related qualifications. For UK-based candidates, compensation will be aligned with Orion’s salary range for the applicable grade. #J-18808-Ljbffr Orion Pharma