
1001 - 5000 employees
Founded 1997
💼 Consulting
🏥 Healthcare
📦 Logistics
Consulting • Healthcare • Logistics
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
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1001 - 5000 employees
Founded 1997
💼 Consulting
🏥 Healthcare
📦 Logistics
Consulting • Healthcare • Logistics
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
• Create and maintain CDASH-compliant eCRF template library and supplementary documentation • Provide technical oversight, support, training and guidance for Sponsors and Ergomed clinical and business development teams • Assist with system validation activities and documentation • Create and review EDC systems for structure, workflow, edit checks, and user roles and permissions • Ensure stakeholder involvement and adherence to EDC creation timelines • Use SAS, SQL, Python, and Power BI to create data listings, reports, quality checks, dashboards, and metrics • Oversee study-level EDC system documentation • Provide technical oversight, training, support, and guidance throughout the study lifecycle • Perform gap analysis for EDC systems not created by Ergomed • Oversee data migrations and coordinate with external vendors regarding transferred or imported data • Manage coding dictionaries, including WHO Drug and MedDRA version updates and licensing • Oversee bi-annual coding dictionary upgrades • Oversee and perform post-live EDC system changes • Oversee and perform site and user account management, including record maintenance and periodic review
• Medidata RAVE and Zelta v1.0 experience is essential • Graduate or bachelor’s degree in Life Sciences, Pharma, or related health discipline from an accredited university or college • Advanced proficiency in data systems • Accreditation in at least one clinical trial EDC system, such as Zelta or Medidata Rave • Experience in EDC system creation and Edit Check programming • Proficiency in data standards (CDASH and SDTM) and application to EDC system creation • CDASH Certification preferred • Effective communication skills • Cooperative and team-oriented approach • Self-motivation and ability to work independently
• Remote work option • Collaborative and passionate team environment • Training, support and guidance throughout the study lifecycle • Opportunity to make a difference to patients' lives • Diverse and inclusive workplace • Growth and professional development opportunities
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