Associate Clinical Research Monitor

Medtronic

10d

About The Position

Medtronic Clinical Research Solutions (MCRS) provides centralized clinical trial support to help execute studies while maintaining quality and compliance. The MCRS Monitoring team represents Medtronic to investigational sites and helps ensure patient safety, site compliance, and data integrity.

The Associate Clinical Research Monitor oversees clinical research activities at investigational sites and conducts onsite and remote monitoring visits. The role ensures studies comply with study protocols, Good Clinical Practice (GCP), regulatory requirements, and Ethics Committee/Institutional Review Board (EC/IRB) policies. It serves as a key contact for study sites and works with study teams and site personnel to resolve issues, review adverse events, identify protocol deviations, and maintain study documentation and reports. The role also supports site training, Ethics Committee submissions, and study operations including clinical trial agreements, invoices, and payments.

This is an entry-level individual contributor position focused on delivering assigned projects under close supervision, with strong attention to compliance and operational detail. The position is based in the Netherlands, requires Dutch and English fluency, and involves 25–75% travel.

Requirements

• Bachelor’s or master’s degree in life sciences, nursing, or another health-related discipline.
• Fluency in Dutch and English.
• Ability to travel 25–75% and a valid driving license.
• Clear and effective verbal and written communication and good interpersonal skills; comfortable working with others.
• Proactivity and ability to work in a fast-paced, changing, and matrix environment.
• Competencies in cross-functional relationships, decision-making, execution/results/process improvement, and customer satisfaction.
• Ability to remain composed in difficult circumstances and adapt to shifting priorities and competing demands, with strong attention to detail and accuracy and good problem-solving skills.
• Ability to work with Word, PowerPoint, Excel spreadsheets, and database applications.

Nice To Haves

• Experience in clinical research monitoring.
• Understanding of applicable regulations and standards, such as GCP training, ICH guidelines, FDA CFR, ISO, clinical research ethics, or the EU Directive.
• Business knowledge or experience in the medical or healthcare industry and knowledge of medical terminology.
• Experience planning, preparing, or executing study submissions to EC/CA.

Responsibilities

• Oversee clinical research at investigational sites and monitor clinical trial progress for compliance with protocols, applicable regulatory standards, EC/IRB policies, procedures, and business policies.
• Conduct onsite and remote clinical trial monitoring in accordance with the Investigational Plan, Monitoring Plan, SOPs, GCP, and applicable regulatory requirements.
• Communicate monitoring visit findings to site personnel and prepare written follow-up letters for the Principal Investigator and appropriate site personnel.
• Prepare site visit reports and correspondence within the timelines specified in the study Monitoring Plan.
• Identify and escalate protocol deviations, data discrepancies, and non-compliance with protocols, regulations, GCP, or SOPs.
• Work with monitoring management and study team personnel to secure Investigator compliance.
• Identify site needs and provide solutions to facilitate the clinical trial process.
• Serve as the main point of contact for study sites as requested.
• Review adverse event cases with investigators, prepare study documents, and issue status reports.
• Understand study protocols and accompanying background information, such as the Investigator Brochure and Report of Prior Investigations.
• Perform initial and ongoing site personnel training as required.
• Attend internal department and study team meetings as requested.
• Adhere to applicable Medtronic policies and procedures.
• Support the Clinical Trial Agreement process and invoice and payment requests.
• Plan, prepare, and execute initial and subsequent study submissions to Ethics Committees and Competent Authorities.

Benefits

• Competitive salary and flexible benefits package.
• Wide range of benefits and resources designed to support employees at every career and life stage.
• Eligible for the Medtronic Incentive Plan (MIP), a short-term incentive.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level