Informed Consent Manager - Clinical Trials Lead

Medtronic; Minneapolis (MN); On-site; USD 133,000 - 199,000; Full time

Job summary

Medtronic is seeking a Consents Manager for the Clinical Research Solutions – Site Activation and Support (MCRS SAS) in Minneapolis, MN. This onsite role leads a US-based team of Informed Consent Specialists and guides consent-related services for clinical studies.

You will own business processes, drive standardization, oversee SOPs/QMS docs, and partner with Legal, Data Privacy, Compliance, and Quality to ensure compliant site activation and study start-up activities.

Qualifications

• Bachelor's degree with 5+ years of clinical research, clinical operations, site activation, study start‑up, or related experience.
• Advanced degree with 3+ years of clinical research, clinical operations, site activation, study start‑up, or related experience.
• 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

Leadership

Cross-functional collaboration

Process improvement

Data-driven decisions

Education

Bachelor's degree with 5+ years

Advanced degree with 3+ years

Job description

Medtronic is seeking a Consents Manager for the Clinical Research Solutions – Site Activation and Support (MCRS SAS) in Minneapolis, MN. This onsite role leads a US-based team of Informed Consent Specialists and guides consent-related services for clinical studies.

You will own business processes, drive standardization, oversee SOPs/QMS docs, and partner with Legal, Data Privacy, Compliance, and Quality to ensure compliant site activation and study start-up activities.