Senior Clinical Data Manager (6-Month Local Role)

Spectraforce; Maple Grove (MN); On-site; USD 69,000 - 117,000; Full time

Job summary

Spectrumforce is seeking a Clinical Database Manager in Maple Grove, MN to lead clinical database development and maintenance, ensure regulatory compliance, and validate deliverables. You will review CRF design, study protocol input, and database specification requirements, and you will set up databases in a clinical data management system, including edit checks.

The role requires collaboration across teams, adherence to SDLC, and the ability to troubleshoot data management systems and support

Qualifications

• Minimum 5 years’ experience in 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.
• Experience with regulatory compliance and FDA 21 CFR Part 11 is preferred.

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 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.

Skills

Analytical thinking

Communication skills

Leadership

Data management

Tools

Oracle Clinical

Oracle Clinical Inform

Oracle Life Sciences Cloud

Job description

Spectrumforce is seeking a Clinical Database Manager in Maple Grove, MN to lead clinical database development and maintenance, ensure regulatory compliance, and validate deliverables. You will review CRF design, study protocol input, and database specification requirements, and you will set up databases in a clinical data management system, including edit checks.

The role requires collaboration across teams, adherence to SDLC, and the ability to troubleshoot data management systems and support