Senior Clinical Data Manager, Clinical Data Management, R&D, Orion Corporation
and 1 more
and 1 more
Job Description
You will join a growing oncology-focused Data Sciences function and serve as the data management lead for oncology clinical trials, responsible for executing and coordinating 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 manage day-to-day activities 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 Data Management input into SDTM mapping activities by ensuring source data structures, eCRF design, data specifications, and data review processes support accurate SDTM conversion, analysis readiness, and regulatory submission deliverables.
- 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.
- Review clinical data listings, data quality reports, reconciliation outputs, and vendor data transfers to identify issues and drive timely resolution.
- 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 in Cambridge, UK and reports to Head of Clinical Data Management.
What you can expect from usAt 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.
What We Are Looking For- 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 the lead data manager for Phase I–III clinical studies, including database build, external data integration, data review, database lock, and submission-readiness activities.
- 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, with experience supporting or reviewing SDTM mapping activities.
- 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.
We typically review applications already during the application period and may start interviewing candidates before the application deadline.
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)
Senior Clinical Data Manager, Clinical Data Management, R&D, Orion Corporation in cambridge at Unknown Company
This position is listed as full time and hybrid.