Medical Monitor – Oncology

🔥 1 minute ago

🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Serve as primary medical point of contact for clinical trial sponsors, internal project teams, investigators and trial sites for medical matters related to the conduct of clinical trials per protocol and per GCP guidelines • Provide medical oversight throughout the conduct of clinical trials in accordance with the protocol, applicable regulations, and ICH-GCP requirements • Respond to medical questions from investigators, sites, sponsors, project teams, and third-party vendors • Provide medical input into eligibility assessments, protocol deviations, participant safety issues, and other trial-specific medical matters • Contribute medical expertise to clinical development plans, protocols, investigator brochures, informed consent documents, annual reports, clinical study reports, patient narratives, and scientific presentations • Review and assess clinical and safety data to support participant safety and identify medically relevant trends, risks, or quality concerns • Prepare and deliver medical and therapeutic-area training to investigators and study teams • Support medical data review activities and contribute to the assessment of aggregated clinical trial data • Participate in bid defense meetings and proposal activities • Provide support with Pharmacovigilance activities • Identify medical trial risks and collaborate with relevant functions to define mitigation and escalation measures • Support or participate in advisory boards, safety monitoring boards, and other medical or scientific committees • Help ensure trial conduct and medical oversight activities comply with the approved protocol, applicable regulatory requirements, and quality standards

🎯 Requirements

• Medical Doctor degree • Board certification in Oncology • Previous experience as a practicing Oncologist • Previous experience in clinical research or the pharmaceutical or CRO industry is a plus • Full professional proficiency in written and spoken English • Strong medical judgement, analytical thinking, and attention to detail • Clear communication and presentation skills, with the ability to explain complex medical information to different stakeholders • A collaborative and solution-oriented approach to working within international, cross-functional teams • Proficiency in Microsoft Office applications • Confidence working with clinical trial systems and digital collaboration tools

🏖️ Benefits

• International team environment • Opportunity to apply oncology expertise across global studies • Collaboration with experienced colleagues • Opportunity to contribute to bringing new treatment options to patients

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