Ophthalmology Data Manager (Remote)

iuvo BioScience, llc.; City of Rochester (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

iuvo Clinical, a full-service ophthalmology-focused CRO, seeks a Data Manager to lead clinical data management activities across trials, interfacing with clinicians, vendors, and sponsors. You will build, maintain, and QA databases, ensuring FDA and GCP compliance while collaborating with statisticians and project teams.

The role involves developing DMPs, managing data transfers, and training junior staff, with remote work options and a focus on data integrity.

Qualifications

• Bachelor’s Degree in relevant discipline or equivalent.
• Minimum of three years’ relevant work experience in data management.
• Strong working knowledge of GCPs and Federal Regulations.
• Current GCP certification required (or willing to obtain).

Responsibilities

• Interface with Project Managers and statisticians to establish data management plans and database schedules.
• Participate in clinical data system design, utilization, and maintenance per FDA guidelines.
• Collaborate with biostatisticians to create analysis datasets.
• Perform database quality assurance audits as needed.
• Develop and maintain the Data Management Plan (DMP) and attachments.
• Train junior data management team members.

Skills

Data management

GCP knowledge

FDA regulations

Communication skills

Analytical thinking

Leadership

Project coordination

Education

Bachelor’s Degree in a relevant discipline

Tools

SAS

Microsoft SQL

Crystal Reports

EDC systems

Job description

iuvo Clinical, a full-service ophthalmology-focused CRO, seeks a Data Manager to lead clinical data management activities across trials, interfacing with clinicians, vendors, and sponsors. You will build, maintain, and QA databases, ensuring FDA and GCP compliance while collaborating with statisticians and project teams.

The role involves developing DMPs, managing data transfers, and training junior staff, with remote work options and a focus on data integrity.