[Hiring] Associate Clinical Research Monitor @Medtronic

Role Description

Medtronic Clinical Research Solutions (MCRS) combines clinical research and evidence generation teams. MCRS provides centralized clinical trial support services that help study execution while maintaining quality and compliance. MCRS enables our vision of being the leading scientific organization delivering innovative clinical research.

The MCRS Monitoring team serves as the face of Medtronic to the investigational site to ensure patient safety, site compliance, and data integrity.

The Clinical Research Monitor/Associate is responsible for overseeing clinical research activities at investigational sites and conducting monitoring visits, both onsite and remotely, to ensure studies are conducted in compliance with study protocols, GCP, regulatory requirements, and Ethics Committee/IRB policies. The role serves as a key point of contact for study sites, collaborating with study teams and site personnel to resolve issues, review adverse events, identify protocol deviations, and maintain accurate study documentation and reports. The role also supports site training, Ethics Committee submissions, and study operations such as CTA, invoice, and payment processes to help drive successful clinical trial execution.

This is an entry-level individual contributor role focused on delivering assigned projects under close supervision, with strong attention to compliance and operational detail.

Primary Responsibilities

• Responsible for the oversight of clinical research conducted at investigational sites and monitors progress of clinical trials to ensure compliance with study protocols, applicable regulatory standards, Ethics committee/Institutional Review Board (IRB/EC) policies as well as procedures and business policies.
• Works under supervision as needed, closely with study management teams, Medtronic field personnel, and site personnel for resolution of site issues towards successful clinical studies execution.
• Performs monitoring activities of clinical trials at the site or remotely and ensures all is conducted, recorded, and reported in accordance with the Investigational Plan, Monitoring Plan, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.
• Communicates visit findings with site personnel and completes a written letter for distribution to the Principal Investigator and appropriate site personnel to follow-up.
• Prepares site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan and within timelines for visit deliverables.
• Identifies and escalates protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures.
• Collaborates with monitoring management and study team personnel towards securing Investigator compliance.
• Identifies site needs and provides solutions to facilitate the clinical trial process.
• Acts as main point of contact for study sites as requested.
• Responsible for reviewing adverse event cases with investigators, preparing study documents, and issuing status reports.
• Understands the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.).
• Performs initial and ongoing site personnel training as required.
• Attends internal department and (study) team meetings as requested.
• Adheres to all applicable Medtronic policies and procedures.
• Supports Clinical Trial Agreement (CTA) process, invoice and payment requests.
• Responsible for planning, preparation, and execution of the study submission to Ethics Committees (EC/CA) for initial and subsequent submissions.

Qualifications

• Bachelor’s or master’s degree in life sciences, nursing or other health-related disciplines.
• Fluent in local language (Dutch) and English.
• Ability to travel (25-75%) and possess a driving license.
• Clear and effective communication verbally and in writing combined with good interpersonal skills and comfort with working with others.
• Proactivity, ability to work in a fast-paced and changing environment, and ability to work in a matrix environment.
• Competencies and essential skills in cross-functional relationships, decision making, execution/results/process improvement, and customer satisfaction.
• Ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands with high attention to detail and accuracy, good problem-solving skills.
• Proficient in Word, PowerPoint, Excel spreadsheets, and database applications.

Preferred Qualifications

• Experience in Clinical Research Monitoring.
• Understanding of applicable regulations and standards (e.g., Training on Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, EU Directive, etc.).
• Business knowledge or experience with the medical/healthcare industry, knowledge of medical terminology.
• Experience in planning/preparing/execution of study submission to EC/CA.

Benefits

• Medtronic offers a competitive salary and flexible benefits package.
• A commitment to our employees' lives at the core of our values. We recognize their contributions. They share in the success they help to create.
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Pay range: Netherlands: 45,600.00 EUR - 68,400.00 EUR.
• The final salary within this range will be determined based on objective, job-related criteria, including relevant experience, skills, and qualifications, in accordance with our compensation framework.
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).