Job Title:
Nearshore Clinical Systems Business Analyst (Clinical, Imaging & EDC Interfaces)

Location:
Nearshore (LATAM Preferred) – Remote

Employment Type:
Contract

Job Summary

We are seeking an experienced
Nearshore Clinical Systems Business Analyst
with strong expertise in
Clinical Operations, Medical Imaging, EDC (Electronic Data Capture) interfaces, and clinical business processes
. The idóneo candidate will bridge business and technology teams, gathering requirements, supporting system integrations, and ensuring seamless data flow across clinical applications while maintaining compliance with GxP and regulatory standards.

Key Responsibilities

Gather, analyze, and document business requirements for clinical systems and business processes.

Work closely with Clinical Operations, Data Management, Medical Imaging, and IT teams to deliver system enhancements.

Support integration and interface development between
EDC systems
, imaging platforms, and other clinical applications.

Understand and document end-to-end clinical trial workflows, including data collection, imaging,



and reporting.

Collaborate with cross-functional stakeholders to define functional specifications and acceptance criteria.

Coordinate User Acceptance Testing (UAT), defect tracking, and validation activities.

Ensure compliance with GCP, GxP, 21 CFR Part 11, and other applicable regulatory requirements.

Identify opportunities for process improvements and recommend best practices.

Support implementation, change management, and production support activities.

Required Qualifications

Bachelor’s degree in Life Sciences, Pharmacy, Computer Science, or a related field.

6+ years of experience as a Business Analyst or Clinical Systems Analyst in the Life Sciences/Pharmaceutical industry.

Hands-on experience with
Clinical Systems
,
Medical Imaging
, and
EDC platforms
.

Experience working with EDC interfaces and system integrations.

Strong understanding of clinical trial processes and clinica

📌 Clinical Business Systems Analyst (Colombia)
🏢 Cygnus Professionals
📍 Colombia