
Medical Monitor – Oncology
Posted 13 hours ago

Posted 13 hours ago
This is a fully remote position, open to applicants in Bulgaria.
• Act as the main medical contact for clinical trial sponsors, internal project teams, investigators, and trial sites.
• Provide medical oversight during clinical trials in accordance with protocols, regulations, and ICH-GCP standards.
• Address medical inquiries from investigators, sites, sponsors, project teams, and third-party vendors.
• Offer medical input on eligibility evaluations, protocol deviations, participant safety concerns, and other trial-specific issues.
• Contribute medical knowledge to clinical development plans, protocols, investigator brochures, informed consent documents, annual reports, clinical study reports, patient narratives, and scientific presentations.
• Analyze clinical and safety data to ensure participant safety and identify significant trends, risks, or quality issues.
• Prepare and conduct medical and therapeutic-area training for investigators and study teams.
• Assist in the review and assessment of aggregated clinical trial data.
• Engage in bid defense meetings and proposal-related activities.
• Support Pharmacovigilance initiatives.
• Identify medical trial risks and work together on mitigation and escalation strategies.
• Support or participate in advisory boards, safety monitoring boards, and other medical or scientific committees.
• Ensure that trial conduct and medical oversight align with approved protocols, regulatory requirements, and quality standards.
• Medical Doctor degree.
• Board certification in Oncology.
• Prior experience as a practicing Oncologist.
• Experience in clinical research or within the pharmaceutical or CRO industry is advantageous.
• Full professional proficiency in both written and spoken English.
• Strong medical judgment, analytical thinking, and meticulous attention to detail.
• Excellent communication and presentation skills, with the ability to convey complex medical information to diverse stakeholders.
• A collaborative and solution-focused approach to working within international, cross-functional teams.
• Proficiency in Microsoft Office applications.
• Comfort in working with clinical trial systems and digital collaboration tools.
• International team environment.
• Opportunity to leverage oncology expertise across global studies.
• Collaboration with seasoned colleagues.
• Chance to contribute to the development of new treatment options for patients.
PSI CRO AG
PSI CRO AG
PSI CRO AG
PSI CRO AG
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