Senior Clinical Data Manager — Lead Data & Submissions

Keralty Group; Bogotá; On-site; COP 120,000,000 - 180,000,000; Full time

Job summary

The Senior Clinical Data Manager role is embedded within Cytel's pharmaceutical client, based in Colombia. You will lead or support data management activities, oversee CROs, manage timelines, ensure archival and inspection readiness, and contribute to regulatory submissions with a strong focus on FDA/ICH standards.

You will collaborate across Data Management, Clinical Operations, and Statistics, driving quality, budget awareness, and continuous improvement while maintaining data integrity

Qualifications

• Bachelor's Degree in science, health related, or information technology field.
• Minimum 5 years experience in Clinical Data Management.
• Strong knowledge of FDA and ICH regulations and industry standards.
• Experience with all phases of development in one or more therapeutic areas preferred.

Responsibilities

• Lead or support data management study activities, CRO oversight, and driving deliverable timelines.
• Strong knowledge of data management best practices & technologies as applied to clinical trials.
• Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and client for all data related deliverables, especially in support of regulatory submissions.
• Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables.

Education

Bachelor's Degree in science/health/IT

Job description

The Senior Clinical Data Manager role is embedded within Cytel's pharmaceutical client, based in Colombia. You will lead or support data management activities, oversee CROs, manage timelines, ensure archival and inspection readiness, and contribute to regulatory submissions with a strong focus on FDA/ICH standards.

You will collaborate across Data Management, Clinical Operations, and Statistics, driving quality, budget awareness, and continuous improvement while maintaining data integrity