Clinical Data Manager

Spectraforce Technologies, Inc.; Maple Grove (MN); On-site; USD 90,000 - 135,000; Full time

Job summary

Spectraforce Technologies, Inc. in Maple Grove, MN is seeking a Clinical Database Manager for a 6-month assignment.

The role involves database development and maintenance for clinical studies, ensuring regulatory compliance, and collaborating across functions to review CRF design and study protocols. Responsibilities include setup of clinical study databases, programming of edit checks, and ensuring data structures support downstream reporting.

Qualifications

• Minimum 5 years' experience in Medical Device, Pharmaceutical or Biopharmaceutical settings.
• Minimum 2 years' experience with a clinical data management system and edit check programming.
• Experience with FDA 21 CFR Part 11 and GCP data-handling procedures.

Responsibilities

• Design, code, configure, test, debug, and document clinical study databases in a CDM system.
• Collaborate with development staff to ensure quality and consistency.
• Escalate live errors and service problems to limit downtime and resolve issues.
• Lead high level design for solutions and influence team decisions.
• Review CRF design, study protocol, and edit check specifications.

Skills

Analytical thinking

Critical thinking

Communication skills

Leadership

Data management

Problem solving

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

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.