BioSpace
Senior Director, Head of Clinical Data Management
BioSpace, King Of Prussia, Pennsylvania, United States, 19406
Overview
Senior Director, Head of Clinical Data Management. The Head of Data Management is a senior leadership role responsible for defining and executing the enterprise-wide data strategy to support clinical development and operational excellence in partnership with CROs. This role oversees governance, quality, integration, and innovation of clinical data to drive decision-making, regulatory compliance, and patient-centric outcomes. Responsibilities
Lead the Data Management function across all therapeutic areas, overseeing teams of data managers, eClinical experts, RBQM experts and technology partners. Develop and implement data governance frameworks, SOPs, and quality standards aligned with GCP, GCLP, and regulatory expectations. Collaborate with Clinical Operations, Biostatistics, Clinical Programming and IT to ensure seamless data flow, integration, and reporting across systems and studies. Drive innovation in data capture, eSource, eCOA, and adaptive trial technologies, ensuring scalability and future-readiness. Represent Data Management in strategic forums and governance bodies, influencing portfolio-level decisions and digital transformation initiatives. Qualifications
Bachelor degree, or equivalent, in Science related discipline; postgraduate qualifications in scientific or business-related field preferable. 10+ years' experience working in clinical data management, statistical programming or clinical systems within the CRO/pharmaceutical environment. Proven leadership and global Clinical Operations experience is essential. Proven track record in leading global teams and implementing enterprise data strategies. Deep understanding of clinical trial processes, regulatory requirements, and digital health technologies. Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. Our benefits support wellbeing with resources from health care to financial protection, designed to assist employees at every life stage. Review the benefits site for details. About CSL Behring
CSL Behring is a global biotherapeutics leader focused on serving patients’ needs by using the latest technologies. We discover, develop and deliver innovative therapies for conditions in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We operate one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people in more than 100 countries. At CSL, Inclusion and Belonging is at the core of our mission. We celebrate diversity and create a culture of curiosity and empathy to better understand and connect with patients, donors, and stakeholders. Learn more about Inclusion and Belonging at CSL. Location
King of Prussia, PA
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Senior Director, Head of Clinical Data Management. The Head of Data Management is a senior leadership role responsible for defining and executing the enterprise-wide data strategy to support clinical development and operational excellence in partnership with CROs. This role oversees governance, quality, integration, and innovation of clinical data to drive decision-making, regulatory compliance, and patient-centric outcomes. Responsibilities
Lead the Data Management function across all therapeutic areas, overseeing teams of data managers, eClinical experts, RBQM experts and technology partners. Develop and implement data governance frameworks, SOPs, and quality standards aligned with GCP, GCLP, and regulatory expectations. Collaborate with Clinical Operations, Biostatistics, Clinical Programming and IT to ensure seamless data flow, integration, and reporting across systems and studies. Drive innovation in data capture, eSource, eCOA, and adaptive trial technologies, ensuring scalability and future-readiness. Represent Data Management in strategic forums and governance bodies, influencing portfolio-level decisions and digital transformation initiatives. Qualifications
Bachelor degree, or equivalent, in Science related discipline; postgraduate qualifications in scientific or business-related field preferable. 10+ years' experience working in clinical data management, statistical programming or clinical systems within the CRO/pharmaceutical environment. Proven leadership and global Clinical Operations experience is essential. Proven track record in leading global teams and implementing enterprise data strategies. Deep understanding of clinical trial processes, regulatory requirements, and digital health technologies. Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. Our benefits support wellbeing with resources from health care to financial protection, designed to assist employees at every life stage. Review the benefits site for details. About CSL Behring
CSL Behring is a global biotherapeutics leader focused on serving patients’ needs by using the latest technologies. We discover, develop and deliver innovative therapies for conditions in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We operate one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people in more than 100 countries. At CSL, Inclusion and Belonging is at the core of our mission. We celebrate diversity and create a culture of curiosity and empathy to better understand and connect with patients, donors, and stakeholders. Learn more about Inclusion and Belonging at CSL. Location
King of Prussia, PA
#J-18808-Ljbffr