[Hiring] Senior Clinical Research Monitor @MiniMed

Role Description

The Senior Clinical Research Monitor is responsible for monitoring and supporting clinical trials to ensure they are conducted in accordance with study protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements. This role works closely with investigators, clinical research organizations (CROs), hospitals, and internal stakeholders to initiate, monitor, and manage clinical studies while ensuring high-quality execution and compliance. This position can be remote within the US.

• Monitor clinical trials at the site level and/or headquarters to ensure compliance with protocols, SOPs, GCP, and regulatory requirements.
• Serve as a liaison with clinical investigators, CROs, hospitals, and research institutions to support the initiation and execution of clinical studies.
• Review adverse events with investigators and ensure appropriate reporting and documentation.
• Manage study timelines, budgets, and schedules; prepare study documents and status reports.
• Train investigators and site personnel on study protocols and requirements.
• Support implementation of clinical development strategies and assist with clinical evaluation projects.
• Identify and recommend qualified investigators and assist with site initiation activities.
• Support patient recruitment and retention efforts.
• Provide guidance to junior clinical research professionals and may lead or manage assigned projects.

Qualifications

• Bachelor’s Degree and 4 years of relevant clinical research experience OR Advanced Degree with 2 years of relevant clinical research experience.

Requirements

• Prior experience monitoring medical device clinical trials.
• Experience working with CROs and managing external research partners.
• Knowledge of global regulatory requirements (e.g., FDA, EU MDR, ISO 14155).
• Experience with electronic data capture (EDC), CTMS, and clinical trial management systems.
• Demonstrated ability to manage multiple clinical sites and prioritize competing timelines.
• Previous experience mentoring junior CRAs or supporting cross-functional clinical study teams.

Benefits

• Competitive salary and flexible benefits package.
• Health, dental, and vision insurance.
• Access to a Health Savings Account and Healthcare Flexible Spending Account.
• Life insurance and long-term disability leave.
• Dependent daycare spending account.
• Incentive plans and a 401(k) plan with company match.
• Short-term disability coverage.
• Paid time off and holidays.
• Participation in the Employee Stock Purchase Plan.
• Access to the Employee Assistance Program.
• Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.