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Main Responsibilities & Accountabilities

•Define and maintain clinical development and operations standards, including protocol templates, CRFs, operational workflows, and data collection frameworks to ensure alignment with regulatory and scientific requirements

•Lead governance of clinical standards across systems, studies, and functions to ensure consistency, compliance, and integration with clinical data standards

•Collaborate with cross-functional teams (e.g., Clinical Operations, Data Management, Regulatory, IT) to embed clinical standards into clinical systems, workflows, and processes

•Monitor compliance with clinical standards, identifying opportunities for process improvements and driving continuous quality enhancements

•Represent the organization in external standards bodies and industry forums (e.g., CDISC, TransCelerate) to ensure alignment with global clinical development trends and best practices

•Support audits, inspections, and regulatory submissions by ensuring traceability, documentation, and adherence to clinical standards

•Provide training, guidance, and support to teams on clinical standards and governance practices, ensuring consistent application across clinical trials

Qualifications & Experience Requirements

•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

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About CSL Behring

CSL 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.

CSL 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.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL (https://www.csl.com/careers/your-well-being) .

You Belong at CSL

At 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.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

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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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement