Remote Clinical Data Manager – Ophthalmology Trials

iuvo BioScience, llc.; United States; Remote; MXN 1,528,000 - 2,037,000; Full time

Job summary

iuvo Clinical is a full-service ophthalmology-focused CRO dedicated to improving patient outcomes by accelerating ophthalmic breakthroughs from concept to commercialization. The Data Manager will serve as the expert in clinical data management, collaborating with clinicians, clients, vendors, and study teams to build and maintain robust trial databases.

The role requires strong knowledge of ICH/GCP guidelines, FDA data handling regulations, and hands-on experience with EDC and CTMS systems.

Qualifications

• Bachelor’s degree in mathematics, statistics, computer science, life science or related discipline.
• Minimum 3 years of relevant work experience in data management.
• Knowledge of GCPs and Federal Regulations; GCP certification preferred.
• Experience with EDC systems and CTMS.

Responsibilities

• Interface with Project Manager(s) and statistician(s) to establish data management plans and requirements and database implementation schedules.
• Participate in system design, utilization, and maintenance to ensure FDA data management compliance.
• Collaborate with biostatisticians in creating analysis datasets.
• Perform database QA audits as needed.
• Provide recommendations to improve project efficiencies.
• Review protocols for CRF design and develop electronic CRFs.
• Complete study-specific database build activities in EDC with design specs and edit checks.
• May train site personnel in EDC/IWR systems and maintain training docs.
• Develop Data Management Plan (DMP) and ensure timely updates.

Skills

GCP & FDA regulations

EDC systems

SAS & SQL

Data analysis & listings

Microsoft Office

Communication skills

Education

Bachelor’s Degree in relevant discipline

Tools

CTMS

Crystal Reports

Microsoft SQL Reporting Services

SAS

SQL

Job description

iuvo Clinical is a full-service ophthalmology-focused CRO dedicated to improving patient outcomes by accelerating ophthalmic breakthroughs from concept to commercialization. The Data Manager will serve as the expert in clinical data management, collaborating with clinicians, clients, vendors, and study teams to build and maintain robust trial databases.

The role requires strong knowledge of ICH/GCP guidelines, FDA data handling regulations, and hands-on experience with EDC and CTMS systems.