Clinical Data Manager - Onsite (Minneapolis)

Planet Pharma; Minnesota; On-site; USD 110,000 - 150,000; Full time

Job summary

Planet Pharma, a leading Medical Device company, is seeking an experienced Study Database Manager (EDC) to join our on-site Minneapolis team.

You will develop and maintain clinical databases, validate deliverables, review CRF designs, and collaborate across cross-functional teams to ensure quality and regulatory compliance.

The role requires 5+ years in medical device/pharma, expertise with Oracle Clinical or similar systems, and strict adherence to FDA 21 CFR Part 11 and GCP.

Qualifications

• Minimum 5 years’ experience in Medical Device/Pharmaceutical/Biopharmaceutical companies.
• Minimum 2 years’ experience using a clinical data management system for study database setup and edit check programming.
• Experience with Oracle Clinical/Inform/OCI cloud or similar systems is preferred.
• Knowledge of FDA 21 CFR Part 11 and GCP data-handling procedures is desired.

Responsibilities

• Develop and maintain study databases; validate deliverables.
• Review CRF design and study protocol; provide input.
• Lead/set up databases in a clinical data management system with edit checks.
• Ensure data structures support downstream reporting and regulatory standards.
• Follow SDLC to design, code, configure, test, and document databases.
• Collaborate with development staff and escalate live errors to limit downtime.

Skills

Clinical data management

Regulatory compliance

Cross-functional collaboration

Problem solving

Database setup

Tools

Oracle Clinical

Oracle Clinical Inform

Oracle Life Sciences Cloud

Job description

Planet Pharma, a leading Medical Device company, is seeking an experienced Study Database Manager (EDC) to join our on-site Minneapolis team.

You will develop and maintain clinical databases, validate deliverables, review CRF designs, and collaborate across cross-functional teams to ensure quality and regulatory compliance.

The role requires 5+ years in medical device/pharma, expertise with Oracle Clinical or similar systems, and strict adherence to FDA 21 CFR Part 11 and GCP.