6 jobs found in Bristol, PA

The Principal Clinical Data Oversight & Standards 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,...

Responsibilities: • Leads or plays a key role in cross-functional teams for the review of safety data or safety-related reports • Mentors and trains newer members of the functional area • Ensures functions to comply with national and international regulations, such as GxP guidelines and/or any other relevant international and national legislation(s), regulations(s), and guidance(s) as well as company policies and procedures in area of responsibility • Ensures direct reports to support and ensure QPPV’s oversight on the company’s Pharmacovigilance system, and identify, implement and monitor KPIs/KQIs across the company and manages cross functional CAPAs and other improvement activities on behalf of the QPPV. • Performs impact assessment of evolving pharmacovigilance legislations and propose or provide strategic direction for implementation of required changes to the global PV system. This may involve cross-functional approaches, including multiple interface functions. • Supports the...

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...

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...

Job Description CSL's 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. Could you be our next Associate Director, Medical Grants and IIS Operations? The job is in our King of Prussia, PA or Waltham, MA Office. This is a hybrid position and is onsite three days a week. You will report to the Director Head of Global Medical, Grants & IIS Operations. You will partner closely with the Director for Grants & IIS to redesign the grants intake and approval process to allow for end-to-end enterprise approach across all grant activities. The role will be responsible for supporting strategic evaluation of all grants applications, ensuring compliant review and...

GENERAL SUMMARY The Director, Commercial and Medical Operations IT Product Manager is a strategic leadership role responsible for driving the vision, roadmap, and delivery of technology platforms that enable operational excellence across commercial and medical domains. This role ensures solutions are innovative, scalable, and compliant, supporting the organization’s transformation and growth.  This individual will serve as a key liaison between business stakeholders and I&T teams, ensuring that product strategies align with organizational goals and deliver measurable value. They will lead cross-functional teams, manage product lifecycles, and champion user-centric design and agile methodologies to deliver scalable, high-impact solutions. This role is accountable not only for technology delivery, but for shaping enterprise-wide business transformation—modernizing operating models, decision-making, and engagement through digital platforms, data, and AI. Success will be...