Medical Monitor – Oncology

This is a fully remote position, open to applicants in Romania.

📋 Description

• Act as the primary medical liaison for clinical trial sponsors, internal project teams, investigators, and trial sites regarding medical matters connected to the execution of clinical trials following the protocol and GCP guidelines.

• Ensure medical oversight during the execution of clinical trials in compliance with the protocol, relevant regulations, and ICH-GCP standards.

• Address medical inquiries from investigators, sites, sponsors, project teams, and third-party vendors.

• Offer medical insights on eligibility evaluations, protocol deviations, participant safety issues, and other trial-specific medical concerns.

• Provide medical expertise for clinical development plans, protocols, investigator brochures, informed consent documents, annual reports, clinical study reports, patient narratives, and scientific presentations.

• Review and evaluate clinical and safety data to enhance participant safety and detect medically relevant trends, risks, or quality issues.

• Prepare and conduct medical and therapeutic-area training sessions for investigators and study teams.

• Assist in medical data review activities and contribute to the evaluation of consolidated clinical trial data.

• Engage in bid defense meetings and proposal processes.

• Support Pharmacovigilance initiatives.

• Identify medical trial risks and work with relevant departments to establish mitigation and escalation strategies.

• Support or be involved in advisory boards, safety monitoring boards, and other medical or scientific committees.

• Help guarantee that trial conduct and medical oversight activities align with the approved protocol, regulatory requirements, and quality standards.

⛳️ Requirements

• Medical Doctor degree.

• Board certification in Oncology.

• Prior experience as a practicing Oncologist.

• Previous 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 capabilities, and meticulous attention to detail.

• Effective communication and presentation skills, with the ability to articulate complex medical information to diverse stakeholders.

• A collaborative and solution-focused attitude while working within international, cross-functional teams.

• Proficiency in Microsoft Office applications.

• Confidence in utilizing clinical trial systems and digital collaboration tools.

🏝️ Benefits

• International team environment.

• Opportunity to leverage oncology expertise in global studies.

• Collaboration with experienced colleagues.

• Chance to contribute to the development of new treatment options for patients.