EDC/Clinical Data Systems Specialist

Planet Pharma United State
Relocation
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AI Summary

Transform clinical trials data into meaningful business value by designing, building, and maintaining EDC systems. Ensure successful study-level and program-level delivery. Collaborate with cross-functional teams to meet study objectives.

Key Highlights
Design and maintain EDC systems
Collaborate with cross-functional teams
Ensure compliance with GCP and ICH guidelines
Key Responsibilities
Design, build, and maintain EDC systems
Ensure EDC systems are optimized for functionality and data flow
Collaborate with Data & Statistical Sciences and cross-functional teams
Technical Skills Required
Medidata Rave CDASH SDTM Project management tools
Benefits & Perks
Target $36–37/hr
Hybrid work preferred; remote considered
Relocation flexibility for conversion

Job Description


EDC / Clinical Data Systems Specialist

Location: Mettawa, IL / Irvine, CA / Florham Park, NJ / Remote

Contract: 2-year contract

Pay Rate: Target $36–37/hr


Schedule: Hybrid preferred; remote considered (conversion requires relocation to an office)

Overview

Our Data Science team is a best-in-class organization responsible for transforming clinical trials data into meaningful business value. This role plays a critical part in ensuring successful study-level and program-level delivery by designing, building, and maintaining Electronic Data Capture (EDC) systems that support high-quality clinical research.

Key Responsibilities

• Design, build, and maintain EDC systems to accurately reflect clinical study protocol requirements

• Ensure EDC systems are optimized for functionality, end-user experience, and data flow

• Deliver EDC builds and updates on time, including integrations with systems such as IRT

• Use project management tools to track progress, manage timelines, and proactively identify risks

• Maintain consistency across therapeutic areas and programs

• Collaborate with Data & Statistical Sciences (DSS) and cross-functional teams to meet study objectives

• Ensure compliance with GCP, ICH guidelines, SOPs, and applicable global regulations

• Stay current on evolving regulatory requirements related to clinical data and technology

• Participate in process improvement and innovation initiatives within DSS

Required Qualifications

• Medidata Rave certification with 3+ years of study build experience

• 3+ years of clinical technology (EDC) experience OR 5+ years in a related clinical development or technical role

• Strong understanding of the clinical trial process

• Working knowledge of CDASH and SDTM standards

• Excellent communication and presentation skills

• Proven ability to adapt in a fast-paced, evolving environment

• Demonstrated ability to influence cross-functional stakeholders without direct authority

• Strong analytical and problem-solving skills

Education

• Bachelor’s degree in life sciences, computer science, MIS, business, or related field

• Master’s degree preferred

Additional Notes

• Hybrid work preferred; remote candidates considered with relocation flexibility for conversion

• Candidates located in CO or NYC may not be considered

• Please include current location on your resume or professional summary


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