2 jobs found in New Castle, DE

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. You will oversees all areas of single case processing in the global pharmacovigilance database from all sources. This includes ensuring that the vendor performs case processing in accordance with regulatory guidelines, PV agreements, and the Company's SOPs, as well as responding to specific questions or queries about cases. This role develops standards and processes, with a focus on global compliance and process optimization. Oversees Medical Evaluators responsible for medical review of ICSRs. Key Responsibilities Oversight of Case Management Processes activities Oversight of Medical Evaluator role which...

The Principal, Clinical Data Management 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...