Clinical Data & Applications Manager

Position Purpose:

The Clinical Data & Applications Manager 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 CDASH and SDTM mapping, eCRF development, and EDC systems (e.g., Medidata Rave, Veeva Vault) to validate datasets, specifications, and vendor artifacts. 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

data platforms and AI-driven automation, enabling more efficient and intelligent use of clinical data.

Reporting Relationships:

This role reports to the Director, Statistical Programming Lead

Work Environment:

*** 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.

Main Responsibilities and Accountabilities:

• Serve as a subject matter expert in CDASH, SDTM mapping, and EDC systems, providing guidance on data standards, eCRF design, and validation approaches to internal teams and external partnersCollaborate with clinical study teams, Standards, 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

• Oversee 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

• Govern 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

• Oversee 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

• Partner 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)

• Lead the development and oversight of data visualization and reporting solutions that provide insights into data quality, study progress, and key metrics to support informed decision-making

• Ensure appropriate data structures, storage, and integration approaches that enable pooled analyses, traceability, and efficient retrieval of both current and legacy clinical data

• Support 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

• Contribute 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

Job Qualifications and Experience Requirements:

Education

• BSc in Computer Science, Mathematics, Statistics or related area with relevant experience

• Other degrees and certifications considered if commensurate with related programming experience

Experience

• 5+ years of relevant experience (clinical data management or related function within a pharmaceutical or CRO environment, with exposure to in-house, hybrid, and/or vendor-supported study models)

• Strong working knowledge of CDISC standards, particularly CDASH, SDTM with practical experience in data mapping, validation, and submission readiness

• Proficiency with EDC systems (e.g., Medidata Rave, Veeva Vault) and understanding of eCRF design and clinical data collection frameworks

• Strong 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

• Proficiency in SAS and familiarity with Python, R, or C# is a plus to support automation and advanced analytics

• Proven ability to manage priorities, meet timelines, and operate effectively in a fast-paced and evolving environment

Competencies

• Good communication and analytical skills

• Good planning and organizational skills

• Ability to work successfully in a matrix organizational structure

• Networking skills and ability to share knowledge and experience amongst colleagues

• Fluent in English, oral and in writing

The 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.

#LI-HYBRID

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.

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.