Clinical Data Architect — Regulated Trials Lead

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

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.