Medical Monitor

Your main responsibilities:

• Oversees clinical trials to safeguard participant safety, data accuracy, and protocol adherence. Addresses any medical issues arising during the study.
• Reviews protocol and related documents and provides expert medical input on the study design, endpoints, and eligibility criteria.
• Conducts safety monitoring, including reviewing adverse events (AEs) and serious adverse events (SAEs), providing causality assessments, and ensuring timely reporting.
• Collaborates with safety committees and Data Safety Monitoring Boards (DSMBs) to provide safety oversight and monitors ongoing safety study data.
• Work closely with clinical, regulatory, and project management teams to ensure Good Clinical Practice (GCP) and regulatory compliance.
• Supports pharmacovigilance efforts to ensure proper safety reporting, manages safety signals throughout the study duration.
• Contributes to business development efforts, participating in project bid proposals and client meetings when requested.
• Collaborates in cross-functional discussions, resolving protocol-related issues and aligning on subject objectives.
• Provides medical/scientific opinion on coding in the Medra system.

You have:

• Minimum of 5 years of experience in clinical research and/or Medical Affairs, with a focus on medical monitoring.
• Clinical experience in practical medicine would be beneficial.
• 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.
• Technical proficiency in Microsoft Office (Excel, Word, PowerPoint) and specific systems (Medra, CTMS, EDC, etc).
• Strong leadership, communication, and collaboration skills, with an ability to engage effectively with diverse teams.

We offer:

• Competitive salary and benefits;
• Annual bonus scheme;
• Flexible working arrangements;
• Career opportunities at local, regional and global levels;
• Support for personal and professional development (trainings, coaching, career development, international assignments, etc).

We provide equal opportunity to all qualified applicants and employees by prohibiting discrimination in employment decisions because of race, color, religion, sex, national origin, age, veteran status or disability.

If you are ready to start your journey at Cromos Pharma, please send your CV to cv@cromospharma.com.