Clinical Data Manager – Study Database Lead

Planet Pharma; Maple Grove (MN); On-site; USD 52,000 - 61,000; Full time

Job summary

Planet Pharma’s Maple Grove, MN site is seeking a Study Database Manager – Data Management to lead clinical database development, validation, and regulatory compliance activities. The role includes CRF design review, database specification review, and edit check programming within a clinical data management system.

The candidate will collaborate across functions, troubleshoot live issues, and contribute to quality deliverables for downstream reporting, while adhering to the company SDLC and GCP

Qualifications

• Minimum 5 years’ experience working for a Medical Device, Pharmaceutical or Biopharmaceutical Company.
• Minimum 2 years’ experience using a clinical data management system performing clinical study database setup including edit check programming.
• Prior experience in Oracle Clinical/Inform or Oracle Life Sciences Cloud.
• Experience with FDA 21 CFR Part 11 and GCP data-handling procedures and guidelines.

Responsibilities

• Follow company software development lifecycle to design, code, configure, test, debug, and document clinical study databases using a clinical data management system.
• Collaborate with other development staff to achieve quality and consistency.
• Problem solver and decision maker with ability to handle multiple tasks simultaneously.
• Actively participate in the escalation of live errors and service problems to limit downtime and resolve problems.
• Team player that develops high level design for solutions.
• Debugs, troubleshoots, and isolates clinical data management systems and offers strategic solutions for future development.
• Ability to work creatively and productively with minimal supervision.
• Participate in the review of clinical research protocols, reports, and statistical analysis plans.

Skills

Clinical data management

Regulatory compliance

Tools

Oracle Clinical

Oracle Life Sciences Cloud

Job description

Planet Pharma’s Maple Grove, MN site is seeking a Study Database Manager – Data Management to lead clinical database development, validation, and regulatory compliance activities. The role includes CRF design review, database specification review, and edit check programming within a clinical data management system.

The candidate will collaborate across functions, troubleshoot live issues, and contribute to quality deliverables for downstream reporting, while adhering to the company SDLC and GCP