Remote Principal eCOA Study Designer

Parexel; Raleigh (NC); À distance; USD 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Résumé du poste

Parexel is hiring a Principal Database Programmer (eCOA Study Builder/Designer) for a remote role in the continental US. You will design, configure, test, and deploy eCOA studies integrated with EDC, ensuring regulatory compliance and data integrity.

You will lead cross-functional collaboration, support UAT, and provide guidance to project teams while maintaining study artifacts and specifications according to SOPs and ICH-GCP. Fluency in English is required.

Qualifications

• Experience with eCOA, ePRO, or eDiary in clinical trials.
• Strong knowledge of SOPs, ICH-GCP, and 21 CFR Part 11.
• Experience with EDC systems and data flow basics.
• Fluency in English, written and spoken.

Responsabilités

• Design, configure, test, and deploy eCOA studies.
• Coordinate eCOA to EDC alignment and study revisions.
• Perform UAT, test evidence, defect triage, and resolution.
• Provide training and guidance to project teams.
• Serve as technical contact for sponsors and vendors.
• Create and maintain eCOA specifications and records.

Connaissances

Questionnaire design

eCOA study configuration

Technical quality control

Cross-functional collaboration

English fluency

Formation

Bachelor's degree in life sciences, computer science, health informatics, clinical research, or related discipline

Outils

Medidata Designer eCOA

Medidata Rave EDC

Description du poste

Parexel is hiring a Principal Database Programmer (eCOA Study Builder/Designer) for a remote role in the continental US. You will design, configure, test, and deploy eCOA studies integrated with EDC, ensuring regulatory compliance and data integrity.

You will lead cross-functional collaboration, support UAT, and provide guidance to project teams while maintaining study artifacts and specifications according to SOPs and ICH-GCP. Fluency in English is required.