689 IT & Software Developer jobs in the US
Data Excellence Lead, Portfolio Development
$75,000 - 105,000
CSL Behring
West 8th Avenue 1020, King of Prussia
$75,000 - 105,000
Requirements
Must:
- Bachelors or Masters degree in Life Sciences, Clinical Research, or a related discipline
- Over 12 years of experience in clinical development, clinical operations, or clinical data standards
- Deep understanding of clinical trial processes, regulatory guidelines (e.g., ICH-GCP), and data standards (e.g., CDASH, SDTM)
- Proven experience in governance, quality management, or standards development, particularly in clinical trial execution and data integrity
- Exceptional communication, documentation, and stakeholder engagement abilities, with a collaborative approach to working across teams and external organizations
Responsibilities
- Establish and uphold clinical development and operational standards, including protocol templates, CRFs, operational workflows, and data collection systems to ensure regulatory and scientific compliance
- Steer the governance of clinical standards across frameworks, studies, and functions to guarantee uniformity, compliance, and integration with clinical data standards
- Collaborate with interdisciplinary teams (e.g., Clinical Operations, Data Management, Regulatory, IT) to incorporate clinical standards into systems, workflows, and processes
- Oversee adherence to clinical standards, pinpointing areas for process improvements and promoting continuous quality advancement
- Represent our organization in external standards bodies and industry forums (e.g., CDISC, TransCelerate) to align with global clinical development trends and best practices
- Assist during audits, inspections, and regulatory submissions by ensuring traceability, documentation, and compliance with clinical standards
- Provide training, guidance, and support to teams regarding clinical standards and governance practices, ensuring consistent application throughout clinical trials
Description
At CSL Behring, we are a leading global biotherapeutics company dedicated to saving lives. We focus on meeting the needs of patients by leveraging advanced technologies to discover, develop, and deliver innovative therapies for conditions across immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Utilizing our strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy, we continuously innovate and improve how our products address unmet medical needs, helping patients lead fulfilling lives. With one of the worlds largest plasma collection networks, CSL Plasma, we are part of a parent company located in Melbourne, Australia, employing 32,000 staff and delivering life-saving therapies to individuals in over 100 countries. We value inclusion and belonging at CSL, fostering a culture of curiosity and empathy to enhance our connection with patients and stakeholders.
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The company with most openings is Robotics technology LLC as they are hiring for 35 different Data Engineer jobs in the United States. They are probably quite committed to find good Data Engineers.
The company with most openings is Robotics technology LLC as they are hiring for 35 different Data Engineer jobs in the United States. They are probably quite committed to find good Data Engineers.