Global eSource Study Design Manager

Science 37; Morrisville, Northern (NC, KY); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Science 37 in Morrisville, NC seeks a Clinical Study Design Manager to define eSource platform design and data capture requirements. You will oversee offshore build teams, bridging protocol requirements with implementation while ensuring quality and efficiency.

You will act as SME for system capabilities, drive templating, and coordinate with Clients, Site Operations, and internal teams to meet milestones and regulatory expectations.

Qualifications

• 3+ years of experience in clinical research or life science industry, including CRF/ePRO design.
• 2+ years of CRIO platform experience.
• Bachelor’s degree or equivalent in health science.
• Knowledge of drug development process and regulatory guidelines.
• Experience in a fast-moving, growth-minded company.

Responsibilities

• Define and specify eSource design requirements for assigned studies, aligning with protocol.
• Collaborate with internal teams and clients to ensure protocol alignment.
• Lead offshore build teams to meet milestones and specifications.
• Serve as SME for system capabilities and data capture configuration.
• Drive efficiency by implementing templates and libraries.
• Monitor project timelines, quality metrics, KPIs and performance.
• Lead build, testing and implementation of direct data capture services.
• Review and revise SOPs and work instructions.
• Train and mentor Platform Build Managers and support staff.
• Oversee user access management for all eSource platforms.
• Partner with Clinical Operations and Data Management for protocol input.

Skills

CRF/ePRO design

Clinical research

CRIO platform

Project management

Data capture configuration

Stakeholder communication

Cross-functional collaboration

Quality standards

Education

Bachelor's degree in health science

Tools

Microsoft Office

Job description

Science 37 in Morrisville, NC seeks a Clinical Study Design Manager to define eSource platform design and data capture requirements. You will oversee offshore build teams, bridging protocol requirements with implementation while ensuring quality and efficiency.

You will act as SME for system capabilities, drive templating, and coordinate with Clients, Site Operations, and internal teams to meet milestones and regulatory expectations.