Job Description

• 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

• 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.

• 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 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.

• Analytical and critical thinking skills along with related prior data management experience.
• Great communication skills with a focus on collaboration.
• Confident in leading discussions and managing complex regulated studies.
• Experience in effectively influencing a team decision to the desired outcome.

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