Informed Consent Operations Manager

Medtronic; Minnesota; On-site; USD 133,000 - 199,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Tuition assistance/reimbursement

Employee Stock Purchase Plan

Job summary

Medtronic Minneapolis-based Consents Manager within MCRS SAS leads a US team of Informed Consent Specialists, guiding performance and growth. You will own resource planning, workflows, and the adoption of best practices to deliver consent services with quality and compliance.

The role requires a bachelor’s degree with 5+ years in clinical research or related fields, cross-functional collaboration, and data-driven process improvements. On-site work with up to 10% travel is expected.

Qualifications

• Bachelor's degree required with 5+ years in clinical research or related field.
• Experience leading projects, processes, or operational activities within a regulated clinical research environment.
• Experience managing cross-functional stakeholders and driving process improvement initiatives.
• Experience analyzing operational metrics and using data to support business decisions and performance improvements.

Responsibilities

• Lead, coach, and develop a team of Informed Consent Specialists to drive performance, engagement, and professional growth.
• Direct resource planning, workload management, and prioritization to ensure timely delivery of consent-related services.
• Serve as the business process owner for the Consents function, driving standardization, optimization, and adoption of best practices.
• Oversee informed consent SOPs and associated Quality Management System (QMS) and non-QMS documentation.
• Monitor operational metrics, analyze performance trends, and implement actions to improve service delivery, quality, and efficiency.
• Partner with clinical Operating Units, Legal, Data Privacy, Compliance, Quality, and other stakeholders to resolve complex consent-related issues.
• Manage escalations and provide guidance on complex operational challenges impacting study start-up and site activation activities.
• Collaborate with Site Activation & Support leadership to improve processes, remove barriers, and reduce site activation cycle times while maintaining compliance and quality standards.

Skills

People leadership

Cross-functional collaboration

Process improvement

Data analysis

Regulated clinical research

Education

Bachelor's degree with 5+ years in clinical research or related field

Job description

Medtronic Minneapolis-based Consents Manager within MCRS SAS leads a US team of Informed Consent Specialists, guiding performance and growth. You will own resource planning, workflows, and the adoption of best practices to deliver consent services with quality and compliance.

The role requires a bachelor’s degree with 5+ years in clinical research or related fields, cross-functional collaboration, and data-driven process improvements. On-site work with up to 10% travel is expected.