Lead Clinical Data Management, ClinicalData 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. 

Working closely with Clinical Operations, Biostatistics, Statistical Programming, Pharmacovigilance, Regulatory Affairs, CRO partners, and external vendors, the Lead Data Manager provides hands-on leadership for data management activities, external data integration, data review, database lock, and data quality oversight across oncology development programs.

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. 

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 https:

//www.orion.fi/en/careers/orion-as-an-employer/.

What are we looking for?

• 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 USD 130,000–230,000 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.

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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.