Senior Clinical Data Management Lead

hace 7 días


Bogotá, Bogotá D.E., Colombia Icon A tiempo completo

**About Us**

We are a world-leading healthcare intelligence and clinical research organization, dedicated to shaping the future of clinical development.

**Role Overview**

This Principal Clinical Data Science Lead role is part of our Early Phase Data Management department. As a Senior Manager/Director of Data Management, you will oversee data management teams, studies, and programs under general direction.

The Principal CDSL will provide planning estimates for project scope, schedule, and resource requirements, ensuring that studies are properly managed and delivered within budget and agreed timelines.

You will work closely with Clinical Operations, Biostatistics, SAS Programming, Medical Writing, and Quality Assurance to ensure data integrity according to corporate standards and regulatory guidelines.

**Key Responsibilities**

- Manage fast-moving early phase studies or programs to meet project objectives within budget and timelines
- Provide input into CRF design, protocol review, edit check specifications, data entry conventions, monitoring guidelines, and other study-related documents
- Ensure the maintenance, cleaning, and lock of EDC study databases

**Requirements**

  • 6+ years of clinical data management experience in a Clinical Research Organization or Pharmaceutical company
  • 3+ years of experience leading studies with key responsibilities for study set-up and close-out tasks
  • Experience with Phase I studies preferred, but not required
  • Strong computer literacy, including Microsoft Office skills
  • Excellent communication, interpersonal, and client relationship management skills

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