3 jobs found in Norristown, PA

Position Purpose: The Senior Programmer for Data Validation 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 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. 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: Senior Director, Programming Director, Programming - Center of...

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. The Director Clinical Operations Lead is accountable for the development of the operational strategy for a clinical study(ies) and/or a clinical program (s) as well as the end-to-end study management and delivery of all operational activities and budget management relating to assigned clinical study (ies)/program(s). Responsibilities encompass support to the development of the operational strategy for our most complex studies and ensuring achievement of all program goals within established timelines, budget, and quality standards, and according to the TA strategies. This role must be experienced in working in a...

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...