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Clinical Study Design Manager
Science 37 🇺🇸 Boston, Massachusetts, United States of America
The Clinical Study Design Manager defines eSource platform specifications and bridges the gap between protocol requirements and technical implementation. They oversee the full lifecycle of the platform, including managing offshore build teams and ensuring quality deliverables through testing and validation.
Responsibilities
- The Clinical Study Design Manager defines eSource platform specifications and bridges the gap between protocol requirements and technical implementation. They oversee the full lifecycle of the platform, including managing offshore build teams and ensuring quality deliverables through testing and validation.
Requirements
- Requires a bachelor's degree in health science and at least 3 years of experience in clinical research, specifically in CRF/ePRO or database capture design. Mandatory experience with the CRIO platform is required along with strong knowledge of drug development and regulatory guidelines.
Key Skills
About Science 37
Science 37 is a modern clinical research site that delivers trials directly to patients’ homes. With nationwide reach and medical licensure across all 50 states, its Direct-to-Patient Site enables sponsors to expand access, improve retention, and enroll more representative patient populations compared to relying solely on a traditional site-based approach. Science 37 operates under a single Form FDA 1572 and a central IRB, supported by centralized medical oversight, research-grade nursing, and specialized direct-to-patient clinical operations. The company has successfully completed multiple FDA inspections, resulting in FDA approvals, achieving No Action Indicated (NAI) classifications with zero Form 483 observations. With more than a decade of experience, Science 37 has supported over 200 clinical trials across Phases I–IV and observational studies. Its model consistently delivers strong performance, including approximately 86% completion rates and contributing an average of 20–30%
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