Clinical Database Manager

Job Title: Clinical Database Manager

Job Location: Maple Grove, MN

Job Type: Contract

Pay Range: $45.00hr - $50.00hr

Job Overview:

Our location in Maple Grove, MN currently has an on-site opportunity for a Study Database Manager and Data Management professional. The Study Database Manager is responsible for clinical database development and maintenance, validation of deliverables, and 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 and study protocols to provide input. The candidate will review database specification functional requirements and Edit Check specifications and provide feedback. The successful candidate will lead and participate in the set-up of clinical study databases in a clinical data management system, including the programming of edit checks, ensuring standards and conventions are followed so that data structure is fit for purpose for downstream reporting.

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.
• Solve problems and make decisions with the ability to handle multiple tasks simultaneously.
• Actively participate in the escalation of live errors and service problems to limit downtime and resolve problems.
• Work as a team player to develop high-level designs for solutions.
• Debug, troubleshoot, and isolate clinical data management systems as well as offer strategic solutions, analysis, and advice regarding identified issues for future development.
• Demonstrate the ability to work creatively and productively with minimal supervision.
• Participate in the review of clinical research protocols, reports, and statistical analysis plans.

Required Qualifications:

• Minimum 5 years of experience working for a medical device, pharmaceutical, or biopharmaceutical company.
• Minimum 2 years of experience using a clinical data management system performing clinical study database setup including edit check programming.

Preferred Qualifications:

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

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities