Manager, Clinical Data Review & RBQM

RXinsider LTD.; Maple Grove (MN); Hybrid; USD 99,000 - 199,000; Full time

Job summary

Abbott is seeking a Manager, Clinical Data Review for on-site leadership in Maple Grove, MN. You will oversee data related to clinical studies, ensure CRF design and data integrity, and drive efficient data management practices across the team, including risk-based quality management and regulatory compliance.

The role requires guiding a diverse data management staff, mentoring subordinates, and maintaining collaboration with executive management to deliver high-quality datasets for analysis.

Qualifications

• Bachelor's degree in a science-related field or equivalent combination of education and experience.
• Minimum 8 years’ progressively responsible experience in pharma, biotech or medical device industry; apply concepts to market development.
• Advanced computer skills in graphics, word-processing, databases, authoring programs, etc.
• Experience in a matrixed, cross-divisional environment; strong leadership and communication abilities.
• Ability to travel approximately 20%, including internationally.

Responsibilities

• Lead data management for clinical studies and ensure dataset integrity.
• Oversee CRF design, edit checks and data collection requirements for analysis.
• Manage RBQM activities including risk assessments and monitoring.
• Hire, coach and mentor data management staff and subcontractors.
• Ensure compliance with FDA regulations and company policies; maintain quality metrics.

Skills

Data management leadership

Regulatory knowledge

Leadership

Communication skills

Education

Bachelor's degree in science-related field

Job description

Abbott is seeking a Manager, Clinical Data Review for on-site leadership in Maple Grove, MN. You will oversee data related to clinical studies, ensure CRF design and data integrity, and drive efficient data management practices across the team, including risk-based quality management and regulatory compliance.

The role requires guiding a diverse data management staff, mentoring subordinates, and maintaining collaboration with executive management to deliver high-quality datasets for analysis.