CSL
Data Excellence Lead, Portfolio Development
CSL, King Of Prussia, Pennsylvania, United States, 19406
Clinical Standards Governance Manager
Lead the development, governance, and continuous improvement of clinical development and operations standards across the organization, ensuring alignment with regulatory requirements and global best practices.
Responsibilities
Define and maintain clinical development and operations standards, including protocol templates, CRFs, operational workflows, and data collection frameworks.
Lead governance of clinical standards across systems, studies, and functional areas to ensure consistency, compliance, and integration with clinical data standards.
Collaborate with cross‑functional teams (Clinical Operations, Data Management, Regulatory, IT) to embed standards into systems, workflows, and processes.
Monitor compliance with standards, identify opportunities for process improvement, and drive continuous quality enhancements.
Represent the organization in external standards bodies and industry forums (e.g., CDISC, TransCelerate) to align with global clinical development trends.
Support audits, inspections, and regulatory submissions by ensuring traceability, documentation, and adherence to clinical standards.
Provide training, guidance, and support to teams on standards and governance practices to ensure consistent application across clinical trials.
Qualifications & Experience
Bachelor’s or Master’s degree in Life Sciences, Clinical Research, or a related field.
12+ years of experience in clinical development, clinical operations, or clinical data standards.
Strong knowledge of clinical trial processes, regulatory requirements (e.g., ICH‑GCP), and data standards (e.g., CDASH, SDTM).
Experience in governance, quality management, or standards development with a focus on clinical trial execution and data integrity.
Excellent communication, documentation, and stakeholder engagement skills, with the ability to work effectively across teams and external bodies.
About CSL Behring CSL Behring is a global biotherapeutics leader dedicated to saving lives through innovative therapies in immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas. We operate the world’s largest plasma collection network and are supported by a parent company of 32,000 employees delivering lifesaving therapies worldwide.
Benefits PSA for additional benefit information available at
How CSL Supports Your Well‑being | CSL .
Equal Opportunity Employer CSL 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 .
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Responsibilities
Define and maintain clinical development and operations standards, including protocol templates, CRFs, operational workflows, and data collection frameworks.
Lead governance of clinical standards across systems, studies, and functional areas to ensure consistency, compliance, and integration with clinical data standards.
Collaborate with cross‑functional teams (Clinical Operations, Data Management, Regulatory, IT) to embed standards into systems, workflows, and processes.
Monitor compliance with standards, identify opportunities for process improvement, and drive continuous quality enhancements.
Represent the organization in external standards bodies and industry forums (e.g., CDISC, TransCelerate) to align with global clinical development trends.
Support audits, inspections, and regulatory submissions by ensuring traceability, documentation, and adherence to clinical standards.
Provide training, guidance, and support to teams on standards and governance practices to ensure consistent application across clinical trials.
Qualifications & Experience
Bachelor’s or Master’s degree in Life Sciences, Clinical Research, or a related field.
12+ years of experience in clinical development, clinical operations, or clinical data standards.
Strong knowledge of clinical trial processes, regulatory requirements (e.g., ICH‑GCP), and data standards (e.g., CDASH, SDTM).
Experience in governance, quality management, or standards development with a focus on clinical trial execution and data integrity.
Excellent communication, documentation, and stakeholder engagement skills, with the ability to work effectively across teams and external bodies.
About CSL Behring CSL Behring is a global biotherapeutics leader dedicated to saving lives through innovative therapies in immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas. We operate the world’s largest plasma collection network and are supported by a parent company of 32,000 employees delivering lifesaving therapies worldwide.
Benefits PSA for additional benefit information available at
How CSL Supports Your Well‑being | CSL .
Equal Opportunity Employer CSL 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 .
#J-18808-Ljbffr