Study Database Manager

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 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.

Preferred Qualifications

• Prior experience in study specific database configuration utilizing Oracle Clinical, Oracle Clinical Inform, or Oracle Clinical One 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.