{"schemaVersion":"jobsearcher.job.v1","id":"0b2a02a3c0d16da490988feb","url":"https://jobsearcher.com/jobs/0b2a02a3c0d16da490988feb","canonicalUrl":"https://jobsearcher.com/jobs/0b2a02a3c0d16da490988feb","title":"Developer, Clinical Data Applications & EDC Systems","description":"Entity: CSL Behring\nJob Category: Research Development & Sciences\nJob Family: Clinical Programming\nJob Type: Full Time\nLocation: Waltham, Massachusetts, United States\nEmployer Reference: R-278024\nJob Description\nPosition Purpose:\n\nThe Developer, Clinical Data Applications & EDC Systems focuses on governance, review, and validation of deliverables to ensure alignment with CSL standards, regulatory requirements, and industry best practices. The incumbent applies strong expertise in leading and overseeing set-up and maintenance of Clinical Data Management Systems in addition to providing technical support. This individual supports cross-functional teams such as Statistics, Data Management and Standards by overseeing and ensuring the quality of clinical data build and programming activities across in-house, hybrid, and vendor-supported studies. The role will contribute to shaping future-state data capabilities by supporting initiatives around scalable\ndata platforms and AI-driven automation, enabling more efficient and intelligent use of clinical data.\nReporting Relationships:\nThis role reports to the Director, Statistical Programming Lead\nWork Environment:\n*** On site / Hybrid at CSL Behring requires a minimum of 3 days in the designated work location office weekly for this role. Relocation and mobility assistance is not provided.\nMain Responsibilities and Accountabilities:\nDrive activities related to the design, development, and maintenance of clinical study databases by applying advanced technical expertise in: CRF design; database build; edit check programming; report development; custom programming; system interface configuration; and the implementation of all relevant systems features to support high-quality, compliant clinical data management.\nCollaborate with clinical study teams, Standards (CDASH/SDTM,CSL), and cross-functional stakeholders to define, implement, and continuously enhance data quality methods, acceptance criteria, and validation rules for eCRF and external data sources across all study models\nOversee the implementation and maintenance of data quality control frameworks, including validation check libraries and acceptance criteria for vendor and internally generated data, ensuring alignment with CSL standards and regulatory expectations\nGovern and maintain a standardized library of reports and listings to support study teams, ensuring consistency, reusability, and efficiency across in-house, hybrid, and vendor-supported studies\nOversee the setup, automation, and monitoring of recurring data quality and operational reports across different models (in-house vs outsourced etc.)a ensuring accuracy, completeness, and timely availability of outputs\nPartner with Data Management, Statistics, and vendors to review and validate clinical data deliverables, ensuring submission readiness in accordance with regulatory standards (e.g., SDTM, define.xml)\nLead the reporting solutions that provide insights into data quality, study progress, and key metrics to support informed decision-making\nEnsure appropriate data structures, storage, and integration approaches that enable pooled analyses, traceability, and efficient retrieval of both current and legacy clinical data\nSupport the integration and governance of external data sources (e.g., IxRS, eDiaries, labs, ECG), ensuring data consistency, quality, and alignment with study requirements, while facilitating collaboration between internal teams and vendors\nContribute to innovation and future-state initiatives by supporting the development of scalable data platforms, automation strategies, and AI-enabled capabilities to enhance data processing, validation, and analytics\nJob Qualifications and Experience Requirements:\nEducation\nBSc in Computer Science, Mathematics, Statistics or related area with relevant experience\nMedidata Rave Study Builder Certification is preferred\nExperience\n5+ years of relevant experience with clinical database design in EDC systems within a pharmaceutical or CRO environment\nExposure to in-house, hybrid, and/or vendor-supported study models\nFamiliarity/practical experience with CDISC standards, particularly CDASH, SDTM including data mapping, validation, and activities supporting submission readiness\nProficiency with EDC systems (e.g., Medidata Rave, Veeva Vault) and understanding of eCRF design and clinical data collection frameworks\nStrong understanding of clinical data processes, including data standards, data flows, and integration of eCRF and external data sources, data quality oversight, validation processes, and vendor deliverable review\nProven ability to manage priorities, meet timelines, and operate effectively in a fast-paced and evolving environment\nAbility to independently perform data migration activities for post-production study changes is preferred\nExperience with C# is preferred and familiarity with SAS, Python, or R is a plus\n\nCompetencies\nGood communication and analytical skills\nGood planning and organizational skills\nAbility to work successfully in a matrix organizational structure\nNetworking skills and ability to share knowledge and experience amongst colleagues\nFluent in English, oral and in writing\nThe expected base salary range for this position at hiring is $143,000 - $169,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed for the Waltham, MA USA work location at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.\n#LI-HYBRID\nAbout CSL Behring\nCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.\nCSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.\nTo learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.\nOur Benefits\nFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL.\nYou Belong at CSL\nAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.\nTo learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging\nEqual Opportunity Employer\nCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.","company":"CSL","rawCompany":"csl","city":"Waltham","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-08-05T01:27:55.469Z","occupations":[{"code":"15-2051.02","title":"Clinical Data Managers","slug":"clinical-data-managers"},{"code":"15-1252.00","title":"Software Developers","slug":"software-developers"},{"code":"15-1243.01","title":"Data Warehousing Specialists","slug":"data-warehousing-specialists"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Developer, Clinical Data Applications & EDC Systems","description":"Entity: CSL Behring\nJob Category: Research Development & Sciences\nJob Family: Clinical Programming\nJob Type: Full Time\nLocation: Waltham, Massachusetts, United States\nEmployer Reference: R-278024\nJob Description\nPosition Purpose:\n\nThe Developer, Clinical Data Applications & EDC Systems focuses on governance, review, and validation of deliverables to ensure alignment with CSL standards, regulatory requirements, and industry best practices. The incumbent applies strong expertise in leading and overseeing set-up and maintenance of Clinical Data Management Systems in addition to providing technical support. This individual supports cross-functional teams such as Statistics, Data Management and Standards by overseeing and ensuring the quality of clinical data build and programming activities across in-house, hybrid, and vendor-supported studies. The role will contribute to shaping future-state data capabilities by supporting initiatives around scalable\ndata platforms and AI-driven automation, enabling more efficient and intelligent use of clinical data.\nReporting Relationships:\nThis role reports to the Director, Statistical Programming Lead\nWork Environment:\n*** On site / Hybrid at CSL Behring requires a minimum of 3 days in the designated work location office weekly for this role. Relocation and mobility assistance is not provided.\nMain Responsibilities and Accountabilities:\nDrive activities related to the design, development, and maintenance of clinical study databases by applying advanced technical expertise in: CRF design; database build; edit check programming; report development; custom programming; system interface configuration; and the implementation of all relevant systems features to support high-quality, compliant clinical data management.\nCollaborate with clinical study teams, Standards (CDASH/SDTM,CSL), and cross-functional stakeholders to define, implement, and continuously enhance data quality methods, acceptance criteria, and validation rules for eCRF and external data sources across all study models\nOversee the implementation and maintenance of data quality control frameworks, including validation check libraries and acceptance criteria for vendor and internally generated data, ensuring alignment with CSL standards and regulatory expectations\nGovern and maintain a standardized library of reports and listings to support study teams, ensuring consistency, reusability, and efficiency across in-house, hybrid, and vendor-supported studies\nOversee the setup, automation, and monitoring of recurring data quality and operational reports across different models (in-house vs outsourced etc.)a ensuring accuracy, completeness, and timely availability of outputs\nPartner with Data Management, Statistics, and vendors to review and validate clinical data deliverables, ensuring submission readiness in accordance with regulatory standards (e.g., SDTM, define.xml)\nLead the reporting solutions that provide insights into data quality, study progress, and key metrics to support informed decision-making\nEnsure appropriate data structures, storage, and integration approaches that enable pooled analyses, traceability, and efficient retrieval of both current and legacy clinical data\nSupport the integration and governance of external data sources (e.g., IxRS, eDiaries, labs, ECG), ensuring data consistency, quality, and alignment with study requirements, while facilitating collaboration between internal teams and vendors\nContribute to innovation and future-state initiatives by supporting the development of scalable data platforms, automation strategies, and AI-enabled capabilities to enhance data processing, validation, and analytics\nJob Qualifications and Experience Requirements:\nEducation\nBSc in Computer Science, Mathematics, Statistics or related area with relevant experience\nMedidata Rave Study Builder Certification is preferred\nExperience\n5+ years of relevant experience with clinical database design in EDC systems within a pharmaceutical or CRO environment\nExposure to in-house, hybrid, and/or vendor-supported study models\nFamiliarity/practical experience with CDISC standards, particularly CDASH, SDTM including data mapping, validation, and activities supporting submission readiness\nProficiency with EDC systems (e.g., Medidata Rave, Veeva Vault) and understanding of eCRF design and clinical data collection frameworks\nStrong understanding of clinical data processes, including data standards, data flows, and integration of eCRF and external data sources, data quality oversight, validation processes, and vendor deliverable review\nProven ability to manage priorities, meet timelines, and operate effectively in a fast-paced and evolving environment\nAbility to independently perform data migration activities for post-production study changes is preferred\nExperience with C# is preferred and familiarity with SAS, Python, or R is a plus\n\nCompetencies\nGood communication and analytical skills\nGood planning and organizational skills\nAbility to work successfully in a matrix organizational structure\nNetworking skills and ability to share knowledge and experience amongst colleagues\nFluent in English, oral and in writing\nThe expected base salary range for this position at hiring is $143,000 - $169,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed for the Waltham, MA USA work location at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.\n#LI-HYBRID\nAbout CSL Behring\nCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.\nCSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.\nTo learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.\nOur Benefits\nFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL.\nYou Belong at CSL\nAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.\nTo learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging\nEqual Opportunity Employer\nCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.","datePosted":"2026-08-05T01:27:55.469Z","dateModified":"2026-08-05T01:27:55.469Z","hiringOrganization":{"@type":"Organization","name":"CSL","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Waltham","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"0b2a02a3c0d16da490988feb"},"url":"https://jobsearcher.com/jobs/0b2a02a3c0d16da490988feb"}}