Clinical Data Manager

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

Our location in Maple Grove, MN currently has an on-site opportunity for a Study Database Manager – Data Management professional. The Study Database Manager is responsible for clinical database development and maintenance; validation of deliverables; adherence to processes, systems, standards, and best practices with attention to quality and regulatory compliance. Through cross-functional collaboration, the Study Database Manager will review Case Report Form (CRF) design, study protocol review and provide input. They will review database specification functional requirements and Edit Check specifications and provide feedback. They will lead and/or participate in set-up of clinical study databases in a clinical data management system including programming of edit checks. Ensure that standards and conventions are followed and data structure is fit for purpose for downstream reporting

What You’ll Work On

• 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 the ability to handle multiple tasks simultaneously.
• Actively participates 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 as well as offers strategic solutions, analysis, and advice regarding identified issues 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.

Required Quali?cations

• 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.

Preferred Quali?cations

• Prior experience in study specific database configuration utilizing Oracle Clinical, Oracle Clinical Inform, or Oracle Life Sciences Cloud or other data management systems.
• Experience in adherence to FDA 21 CFR Part 11 and Guidance for Good Clinical Practices (GCP) data-handling procedures and guidelines.

Pay ranges between 38-44/hr based on experience