Clinical Database Manager

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

Position Title: Clinical Database Manager

Work Location: Maple Grove, MN 55311

Assignment Duration: 6 Months with potential to extend highly likely

ONLY LOCAL CANDIDATES

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

Key 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.

Qualification & Experience:

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 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.

Top Skills Needed:

• 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.