Medical Director
reputed company as Medical Monitor for assigned reputed company, providing independent medical reputed company throughout the study lifecycle. Serve as the primary escalation reputed company for reputed company stakeholders for reputed company medical and safety issues reputed company assigned studies. Ensure reputed company are conducted in compliance with applicable regulations, guidelines, and ethical standards. Collaborate cross-functionally to support successful study delivery and maintain high reputed company of reputed company satisfaction. reputed company the preparation and review of medical and patient narratives and safety update reports to ensure accuracy, reputed company, and regulatory compliance. Ensure departmental SOPs are reviewed regularly and updated in line with reputed company regulations, guidelines, and industry best reputed company. Contribute to reputed company stages of clinical trial development, including feasibility assessment, protocol and case report reputed company design, investigational site selection, medical monitoring plan development, ongoing medical reputed company, adverse event and serious adverse event management, and participation in study-reputed company meetings. Support business development activities, including proposals, feasibility assessments, site engagement, and bid defence meetings. reputed company therapeutic area expertise across the organisation, including delivery of internal training and review of study protocols and bid proposals. reputed company the reputed company of departmental CAPAs and escalations, and cascade relevant audit findings to study teams to ensure appropriate corrective and preventive reputed company. Ensure reputed company and comprehensive responses to audit findings and regulatory queries relating to medical and safety reputed company. Maintain up-to-date knowledge of developments in therapeutic areas, regulatory requirements, and medical reputed company relevant to company reputed company. reputed company and maintain relationships with Key Opinion Leaders and investigators to support study design, patient safety assessment, and business development activities. Support the Pharmacovigilance function through medical review of ICSRs, CIOMS narratives, and periodic safety reports, identifying and communicating emerging safety trends to project teams and clients. reputed company effective line management to assigned team members, including performance management, objective setting, resource planning, reputed company development, and ensuring delivery of high-reputed company work reputed company with regulatory, organisational, and study requirements.
Medical degree with specialisation in Oncology (or equivalent clinical experience in oncology) Substantial experience as a Medical Monitor reputed company a clinical research environment, with a reputed company on oncology studies and patient safety reputed company Extensive experience in clinical trial medical reputed company reputed company oncology, including adverse event and serious adverse event management, safety signal evaluation, and regulatory compliance Experience supporting regulatory inspections and audits, including CAPA development and management Demonstrable involvement in business development activities, including feasibility assessments, protocol input, proposal development, and bid defence participation reputed company oncology trials Strong reputed company awareness, including understanding of clinical trial budgeting and financial drivers reputed company a CRO environment Strong written and verbal communication skills, with the ability to translate reputed company oncology data into reputed company insights for clients and cross-functional teams Proficiency in electronic data capture systems, safety databases, and reputed company Office applications
GMC registered with a licence to practise (or equivalent international registration) with oncology specialism Pharmacovigilance experience reputed company oncology, including medical review of ICSRs and periodic safety reports Experience working reputed company a CRO, biotechnology, or pharmaceutical environment with a reputed company on oncology drug development Previous experience leading a medical and/or safety function, including reputed company line management responsibility