6 jobs found in Elkton, MD

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...

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...

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...

The Senior Statistical Programmer is responsible for providing hands-on support and technical guidance on clinical study teams. The development of study and ad hoc output including, but not limited to: ADaM datasets, tables, figures and listings output and/or QC of requested output is the main focus of this role. This individual, working closely with the study statistician will be responsible for review and acceptance of contract research organization (CRO) deliverables which are mainly, but not limited to, datasets in submission ready standard format (ADaM), tables, figures and listings and submission packages. This individual will participate in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses. This individual will interface with other departments (eg, Biostatistics, Data Management, Regulatory Operations, Medical Writing, ESP teams) to...

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...

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...