Data Manager, Expert in Programming, EDC Systems

🔥 20 hours ago

🌐 New Zealand, India – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

📊 Data Scientist

👻 Ghost score 17%

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Logo of ERGOMED

ERGOMED

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.

📋 Description

• Perform database testing and validation of EDC systems and associated data management reports or listings • Validate EDC and SAS edit checks • Manage and create EDC user accounts • Update and maintain data management documentation • Support database specifications, database build, and user acceptance testing • Enter trial-document data into data entry systems when required • Perform medical coding when required • Manage, review, and track local and central laboratory reference ranges • Attend internal and external teleconferences as needed • Create and review study metric reports • Notify management of process roadblocks and propose solutions • Provide the Project Data Manager with status updates • Escalate significant issues to the study team • Support study close-out activities and database lock checklist tasks, including query resolution, final reconciliations, and report development

🎯 Requirements

• Bachelor's Degree, preferably in Life Sciences, Computer Science, or another related scientific discipline • 4–8 years of relevant clinical data management experience in the pharmaceutical industry, contract research organization, or similar data management experience in a non-clinical environment • Experience with EDC systems and associated data management reports or listings • Experience validating EDC and SAS edit checks • Experience with database specifications, database build, and user acceptance testing • Experience with query management, lab reference ranges, serious adverse event reconciliation, and vendor data reconciliation • Experience with medical coding may be required • Ability to support multiple moderate-complexity or complex trials with minimal supervision

🏖️ Benefits

• Passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting • Diverse and inclusive workplace where every voice counts • Opportunity to make a real difference to patients' lives • Growth opportunities • Remote work arrangement

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