Clinical Data Standards Manager
vor 2 Wochen
Clinical Data Standards Manager (CDSM) The Clinical Data Standards Manager is a functional expert in the field of clinical data standards as defined by Regulatory Authorities and Industry Organizations, such as CDISC, and as required for clinical data submissions. The CDSM advises and supports the Clinical Data Manager (CDM), Data Management Lead (DML) and the broader Clinical Trial Team (CTT) to ensure that clinical data is completed, accurate and consistent and meet the standards of quality for analysis and reporting to regulatory bodies, compliant with the local and global regulations. ROLES AND RESPONSIBILITIES The CDSM will: Take a leadership role in cross-functional teams to create data standard driven end-to-end processes and solutions that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and regulatory requirements. Serve as a subject matter expert on all aspects of clinical data standards development that includes industry standards and regulations. Set up, lead or/and contribute actively in the Data Standards Governance meetings. Provide support to optimize data acquisition in clinical trials by exploring opportunities to streamline and integrate data, enhancing efficiency and data quality. Support and implement future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal and external stakeholders. Keep abreast of Industry and Regulatory Authority requirements related to data standards and data submission, interpret published data standards guidance documentation and perform impact assessments to decide on a strategy for implementation In support of the argenx clinical trial portfolio, the CDSM will: Develop and maintain the argenx Clinical Data Standards library Support CDM and DML in creation of study specific unique CRFs and SDTM metadata, implementing clinical data standards on trial level Ensure proper training of the CDM and other internal teams in the use of the argenx clinical data standards. Support CDM with review of the SDTM conversion and data QC on trial level. Perform proper issue escalation to other members of the CTT and/or Indication Development Team (IDT) as required The CDSM will also participate in other activities but are not limited to: Lead/participate in initiatives on process improvements focussed on data standardization Participate in regulatory agency inspections and internal audits, when appropriate SKILLS AND COMPETENCIES Knowledge of ICH-GCP and other applicable legislation CDISC standards (SDTM, CDASH) Eye for detail, analytical skills Able to work independently Strong communication and interpersonal skills Fluent in English (written and spoken) EDUCATION, EXPERIENCE AND QUALIFICATIONS Master’s or Bachelor’s degree in Life Sciences, Information Technology or equivalent by experience At least 8 years experience in Clinical Data Management (Biotech experience is a plus) Experience of working in a Data Standards team In depth understanding of Clinical Development processes Good knowledge of the applicable regulatory guidelines
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Safety Evidence
vor 2 Wochen
Gümligen, Schweiz Argenx VollzeitThe Safety Evidence (Medical) Lead generates insights relevant for argenx products and competitors with focus on safety. This may include the identification, collection, integration, and evaluation of data from various external sources including internal safety database, external health data, PAS, medical literature or others.This role combines...
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Safety Evidence
vor 1 Woche
Gümligen, Schweiz Argenx VollzeitThe Safety Evidence (Medical) Lead generates insights relevant for argenx products and competitors with focus on safety. This may include the identification, collection, integration, and evaluation of data from various external sources including internal safety database, external health data, PAS, medical literature or others. This role combines...
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Working student in Business Intelligence
vor 24 Stunden
Gümligen, Schweiz Schneider Electric VollzeitWorking student in Business Intelligence / Data Analytics (f/m/d) – Schneider Electric – Gümligen / Crissier, Switzerland Start: Immediate, for at least 12 months. Contact: Jürgen Lieber. Responsibilities Ensure data quality in the CRM system, including correct customer segmentation, types of customers, potentials, and contacts. Train the sales...
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Senior Sourcing Manager, Preclinical
vor 2 Wochen
Gümligen, Schweiz Argenx VollzeitPURPOSE OF THE FUNCTION Sourcing and selection of external vendors/partners for support of argenx development projects, with responsibility for contract negotiation, preparation and performance. Direct business relationship with argenx preclinical external vendors/partners (including pharmacology, toxicology, bioanalytical), ensuring that they deliver...
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Senior Medical Director Indication Lead
Vor 3 Tagen
Gümligen, Schweiz Argenx VollzeitIt is an exciting time of growth for argenx as we strive to achieve our VISION 2030. Vision 2030 includes the following goals: 50,000 patients globally on treatment with an argenx medicine, 10 labeled indications across all approved assets, including VYVGART and potentially empasiprubart, ARGX-119 and five new molecules in Phase 3 development.The Global...
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Senior Sourcing Manager, Preclinical
vor 2 Wochen
Gümligen, Schweiz Argenx VollzeitPURPOSE OF THE FUNCTIONSourcing and selection of external vendors/partners for support of argenx development projects, with responsibility for contract negotiation, preparation and performance.Direct business relationship with argenx preclinical external vendors/partners (including pharmacology, toxicology, bioanalytical), ensuring that they deliver quality...
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Gümligen, Schweiz Argenx VollzeitJoin argenx At argenx, we build our culture from the collective power of the team and the knowledge that together, we are better. If you are entrepreneurial, curious and committed to make a difference for patients and thrive on creating solutions for rare autoimmune diseases, then argenx is for you.Next to a competitive salary with extensive benefits, we...
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Channel Development Manager Alpine
vor 2 Wochen
Gümligen, Schweiz Rubrik VollzeitJob Summary As a Channel Development Manager for the Alpine region, you will play a pivotal role in growing Rubrik’s channel business by developing and nurturing strategic partnerships. You will drive partner enablement, execute targeted sales acceleration initiatives, and generate pipeline growth through proactive planning and collaboration. Working...
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Medical Information Director – Customer Management
vor 2 Wochen
Gümligen, Schweiz Argenx Vollzeitargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is...
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Business Development Manager
vor 2 Wochen
Gümligen, Schweiz Smallpdf GmbH VollzeitAbout Us Pdftools is on a mission to empower people and businesses to share documents with trust and confidence, today and in the future! In over 70 countries, more than 650 customers trust our PDF technology to power their mission-critical business processes. As a pioneer in the PDF industry since 1994, we have been instrumental in shaping the PDF standard...
