Sr. Medical Monitor (extensive oncology experience required) Join to apply for the Sr. Medical Monitor (extensive oncology experience required) role at ERGOMED PrimeVigilance (part of Ergomed PLC) is a specialised mid‑size pharmacovigilance service provider established in 2008. We serve pharmaceutical and biotechnology partners across Europe, North America and Asia in Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. We value employee experience, well‑being and a healthy work‑life balance, and we invest in training and development. Role and Responsibilities Provide medical guidance to site personnel and the project team regarding protocol and other study‑specific medical aspects. Offer 24/7 medical consultancy support to investigators and the project team. Monitor patient safety and well‑being: detect trends and outliers, perform signal detection, check eligibility, and review selected laboratory parameters. Review protocol deviations and propose grading from a medical/safety perspective. Maintain a subject discontinuation list and monitor specific safety parameters related to the investigational medicinal product (IMP) or assay (AxMP). Create and review case/narratives, and support SAE reconciliation with the Safety Department. Present medical monitoring (MM) reports and safety data to the study team. Review and contribute to study‑related documents, including the development of the MM plan. Participate in kick‑off meetings, investigator meetings and safety committee meetings (DSMB, IDMC, SRC). Train the project team and investigators on indications, IMP, AxMP and other medical aspects of the study. Review medical coding for congruency with the case report form and provide recoding of events if appropriate. Oversee study personnel activities and review site visit reports. Qualifications Medical Doctor degree; board certification and/or medical specialty is appreciated. Practical clinical research experience. Highly organized with strong interpersonal skills. Proven efficiency in timely delivery. Proficiency in MS Office (Word, Excel, PowerPoint) and practical use of Microsoft Teams and SharePoint. All information will be kept confidential according to EEO guidelines. Seniority Level: Mid‑Senior Employment Type: Full‑time Job Function: Other (Pharmaceutical Manufacturing) #J-18808-Ljbffr ERGOMED
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