Data Excellence Lead, Portfolio Development

Waltham, MA - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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

Bachelors or Masters 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

#LI-Hybrid

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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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 and CSL Plasma at 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 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

Main Responsibilities & AccountabilitiesDefine and maintain clinical development and operations standards including protocol templates CRFs operational workflows and data collection frameworks to ensure alignment with regulatory and scientific requirementsLead governance of clinical standards across...