The Principal Clinical Data Oversight & Standards Lead provides leadership and oversight for clinical data build, programming, and vendor deliverables across in-house, hybrid, and outsourced studies, ensuring alignment with CSL standards, regulatory requirements, and industry best practices.
The role drives governance, review, and validation processes; leads the implementation of CDASH and SDTM standards; and oversees scalable validation frameworks and data quality controls. Additionally, it ensures effective integration of internal and external data into platforms such as the CSL Clinical Data Warehouse, while advancing automation, AI-driven solutions, and strong cross-functional collaboration with Biostatistics, Data Management, Standards, and external partners
Main Responsibilities and Accountabilities:
Leads and develops a team of Clinical Data Validators, providing direction on clinical data standards, validation, and oversight activities across in-house, hybrid, and vendor-supported studies.
Establishes and drives clinical data governance frameworks, including review and validation processes for eCRF builds, SDTM datasets, specifications, and vendor deliverables, ensuring compliance with internal standards, regulatory requirements, and industry best practices.
Oversees the development, implementation, and continuous improvement of clinical data standards (e.g., CDASH, SDTM) and associated validation check libraries to enable consistent, scalable, and high-quality data across studies.
Provides strategic oversight of data integration processes, including external data flows and system interfaces, ensuring accurate, efficient, and compliant data ingestion into downstream platforms such as the Clinical Data Warehouse.
Ensures submission readiness of clinical data by establishing robust quality control frameworks and validation processes aligned with regulatory expectations (e.g., SDTM, ADaM, define.xml).
Develops, maintains, and governs departmental and cross-functional SOPs, standards, and QMS documentation related to clinical data oversight, standards, and programming.
Drives cross-functional alignment by partnering with Biostatistics, Data Management, Standards, and external partners to ensure consistent understanding and application of clinical data standards and quality expectations; provides guidance, knowledge sharing, and targeted training to support effective implementation across studies.
Provides oversight and guidance on data storage, archival, and retrieval strategies to support regulatory submissions, pooled analyses, and reuse of legacy data in collaboration with Biostatistics and other stakeholders.
Oversees programming and validation support to ensure availability of high-quality, analysis-ready datasets, while promoting automation, efficiency, and innovation through the use of SAS and emerging technologies (e.g., Python, AI-driven solutions).
Job Qualifications and Experience Requirements:
Education
Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area with relevant experience.
Other degrees and certifications considered, if commensurate with related data management/statistical programming experience
Experience
At least 7 years of relevant experience with EDC and/or Clinical Data Warehouse platforms (e.g., Medidata Rave, Veeva Vault), with a solid understanding of data flows, integrations, and database structures within the CRO/pharmaceutical environment
Significant experience with demonstrated leadership or oversight responsibilities and a strong understanding of the end-to-end clinical data lifecycle, including data collection, validation, standards implementation, and regulatory submission requirements.
Proven expertise in CDISC standards (CDASH, SDTM, ADaM) and their practical application across studies, including review and oversight of datasets, specifications, and mappings
Proficiency in SAS programming, with working knowledge of Python, R, or similar languages preferred to support automation and advanced data review.
Demonstrated experience in establishing or applying data quality frameworks, validation processes, and governance models in a clinical data environment.
Proven ability to manage priorities, timelines, and team deliverables in a fast-paced environment, while driving continuous improvement and operational excellence.
Experience with CROs (either managing a CRO, or having worked in a CRO)
Competencies
Excellent communication and analytical skills.
Strong interpersonal and effective leadership skills.
Excellent organizational skills and ability to prioritize individual and team workloads.
Strong ability to lead and collaborate across cross-functional, global teams, including oversight of vendor deliverables and alignment with internal stakeholders such as Biostatistics, Data Management, and Standards.
Is able to identify and engage internal and external expertise as needed.
Proven networking skills and ability to share knowledge and experience amongst colleagues.
Strong written and verbal English communication skills
Work Environment: On-Site Hybrid Requires a minimum of 3 days a week in office work location
The expected base salary range for this position at hiring is $170,000 - $201,000 USD. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed for Waltham, MA USA 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.
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About CSL BehringCSL 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/.
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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.
