Medical Monitor

Medical Monitor

Location: German, Ireland or Spain

Summary

Are you passionate about advancing access to innovative treatments for rare and serious conditions? Are you ready to work in a fast-growing, collaborative environment focused on shaping the future of clinical research? We’re seeking an experienced Medical Monitor to join our team and contribute to impactful clinical programs during an exciting growth phase.

About Us

We specialize in providing global Expanded Access and Post-Approval Named Patient Programs, bringing treatments to patients in over 120 countries. With more than 15 years of industry expertise, our team is dedicated to delivering therapies to patients who need them most.

Role Overview

As a Medical Monitor, you will be the clinical and scientific expert for trial protocols and Expanded Access Programs, ensuring the accuracy, quality, and compliance of clinical studies. This role is essential in guiding investigators and internal/external teams to uphold study protocols and meet the highest standards in scientific and ethical research practices.

Key Responsibilities

• Act as the main medical point of contact for investigators, regulatory bodies, and internal teams, clarifying protocols and ensuring consistent interpretation.
• Oversee clinical trials and Expanded Access Programs to safeguard participant safety, data accuracy, and protocol adherence.
• Address any medical issues arising during the study.
• Organize and lead investigator calls to discuss eligibility criteria and enhance site selection and recruitment processes.
• Conduct safety monitoring, including reviewing adverse events (AEs) and serious adverse events (SAEs), providing causality assessments, and ensuring timely reporting.
• Collaborate with safety committees and Data Safety Monitoring Boards (DSMBs) to provide safety oversight and monitor ongoing trial data.
• Deliver training to investigators and site staff on protocol and therapeutic area to ensure protocol adherence and comprehension.
• Review protocol documents and provide expert medical input on study design, endpoints, and eligibility criteria.
• Identify and resolve protocol deviations, maintaining the scientific integrity and ethical standards of the study.
• Work closely with clinical, regulatory, and project management teams to ensure Good Clinical Practice (GCP) and regulatory compliance.
• Support pharmacovigilance efforts to ensure safety reporting and manage safety signals throughout the trial.
• Contribute to business development efforts, participating in project bid proposals and client meetings when requested.
• Collaborate in cross-functional discussions, resolving protocol-related issues and aligning on trial objectives.

Qualifications

• MD or PhD in a health-related field is required.
• Minimum of 5 years of experience in clinical research, with a focus on medical monitoring.
• Familiarity with Expanded Access, Compassionate Use, or Named Patient Programs is advantageous.
• Proven background in protocol development, implementation, and data interpretation.
• Expertise in safety monitoring and adverse event reporting within clinical trial settings.
• Solid knowledge of clinical trial design, regulatory standards, and drug development.
• Proficient in Microsoft Office (Excel, Word, PowerPoint).
• Strong leadership, communication, and collaboration skills, with an ability to engage effectively with diverse teams.
• Analytical mindset with problem-solving capabilities, well-suited to the healthcare sector.
• Ability to travel domestically and internationally up to 25%.

What We Offer

We’re dedicated to creating a supportive work environment that values collaboration and empowers our employees. As part of our team, you’ll engage in meaningful work that contributes to improving patient lives. We offer a competitive salary and benefits, including comprehensive health insurance, annual bonuses, a development allowance, pension schemes, flexible summer hours, and company social events. Join us to be a part of a team that makes a difference