Clinical Data Manager
Spectraforce Technologies
Position Title: Clinical Database Manager Work Location: Maple Grove, MN 55311 Assignment Duration: 6 Months with potential to extend highly likely Position Summary:
- 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.
Vacancy posted 2 days ago
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