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

Lead Clinical Data Management, ClinicalData Management, R&D, Orion Corporation Job Description Lead Clinical Data Management provides strategic and operational leadership for clinical data management activities across oncology development programs spanning Phase I–III clinical trials. Reporting to the Head of Clinical Data Management, this role is responsible for ensuring the delivery of high-quality, inspection-ready, and submission-ready clinical data that support development decisions, regulatory submissions, and corporate objectives. Lead Clinical Data Management partners closely with Clinical Operations, Biostatistics, Statistical Programming, Pharmacovigilance, Regulatory Affairs, CRO partners, and external vendors to establish data management strategy, drive operational excellence, and ensure consistent application of industry standards and best practices. Responsibilities Provide leadership for clinical data management activities across multiple oncology studies and development programs. Serve as the senior Data Management representative on cross‑functional program teams and contribute to strategic development planning. Define and implement data management strategies that support efficient study execution, regulatory compliance, and submission readiness. Lead the design and development of eCRFs, database builds, edit checks, derivations, data review plans, and study‑level data management documentation. Ensure effective integration, reconciliation, and quality oversight of external data sources including laboratory, imaging, ePRO, genomic, biomarker, and safety data. Drive data quality initiatives and ensure timely resolution of data issues through proactive review, risk‑based approaches, and operational metrics. Lead database lock planning and execution activities and ensure delivery of high-quality datasets supporting statistical analysis and regulatory submissions. 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. Lead evaluation and adoption of AI‑enabled technologies, automation platforms, and advanced analytics solutions that improve data quality, operational efficiency, query management, and risk detection. Establish governance and best practices for responsible use of AI‑assisted data review and automated workflow solutions within clinical development. Contribute to department strategy, resource planning, talent development, and organizational objectives established by the Head of Clinical Data Management. This role can be based in Cambridge (MA) or in Cambridge, UK, and reports to Head of Clinical Data Management. What you can expect from us At Orion Pharma, your work impacts millions of lives around the world. With us, you get to work on challenges that matter and see the difference your work makes every day. We believe our people are the key to our success, which is why we invest in your continuous learning. Our innovative products are world‑class, and we take sustainability and ethics seriously. Rooted in our Nordic heritage, we value teamwork, low hierarchies, and a culture where every voice is heard. We are builders of well‑being and offer jobs with a clear purpose: helping people live their lives to the fullest. Please visit our website to find further information about our values and Orion as an employer 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. How to apply Please send your application with the latest CV and cover letter by July 26th, 2026. The expected annual salary range for this position is USD130,000–230,000 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. We typically review applications already during the application period and may start interviewing candidates before the application deadline. Therefore, we invite you to send your application as soon as possible. Your new team Orion’s pharmaceutical innovations are created within its R&D organization. We employ over 400 top professionals in the field of drug discovery and development. We work globally: in Espoo and Turku in Finland, in Nottingham and Cambridge in the UK, and in Cambridge, MA, USA. Orion R&D and the Innovative Medicines business division are dedicated to making a transformation to become a global player in the pain and oncology therapy areas. About Us Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well‑being for over a hundred years. We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future. Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more. We offer careers with a clear purpose: empowering people to live their lives to the fullest. Locations: One Broadway, Cambridge, Massachusetts, 02141, US – The Bennett building, B930 Babraham Research Campus, Cambridge, CB22 3AT, GB (Hybrid) #J-18808-Ljbffr Orion Pharma