Clinical Data Manager: Automate & Optimize EDC

Planet Pharma; Arizona; On-site; USD 85,000 - 120,000; Full time

Job summary

Planet Pharma seeks a Clinical Data Manager to oversee data collection, cleaning, validation, and EDC system activities across assigned trials. The role emphasizes Python scripting for automation, data transformations, and ensuring GCP/21 CFR Part 11 compliance while collaborating with cross-functional teams including operations and biostatistics.

Qualifications include a Bachelor’s degree in Life Sciences or related field, 2+ years in clinical data management, and experience with Medidata Rave

Qualifications

• 2+ years of clinical data management experience within clinical trials.
• Advanced Python scripting for automation and data manipulation.
• Experience with EDC platforms like Medidata Rave, Veeva Vault CDMS, REDCap, Oracle InForm.
• Proficiency in GCP, 21 CFR Part 11, and regulatory audit readiness.

Responsibilities

• Oversee data collection, cleaning, and validation across assigned trials.
• Design, develop, and test EDC systems, UAT, and data validation specs.
• Manage query generation, reconciliation, and resolution with sites and CRO partners.
• Develop and execute Python scripts to automate data extraction, validation, and metrics reporting.
• Collaborate with Clinical Operations, Biostatistics, QA, and Site Management to meet milestones.

Skills

Python scripting

SQL

R

SAS

Education

Bachelor's Degree in Life Sciences, Computer Science, Health Informatics, Data Science, or related field

Master's degree preferred

Tools

Medidata Rave

Veeva Vault CDMS

REDCap

Oracle InForm

Job description

Planet Pharma seeks a Clinical Data Manager to oversee data collection, cleaning, validation, and EDC system activities across assigned trials. The role emphasizes Python scripting for automation, data transformations, and ensuring GCP/21 CFR Part 11 compliance while collaborating with cross-functional teams including operations and biostatistics.

Qualifications include a Bachelor’s degree in Life Sciences or related field, 2+ years in clinical data management, and experience with Medidata Rave