Clinical Project Manager
hace 4 días
City of London
Location: Nucleus Network – Hammersmith Medicines Research - London Why Join Us? You’ll be part of a dynamic team committed to advancing clinical research with integrity and innovation. We offer a collaborative environment, opportunities for professional growth, and the chance to make a meaningful impact in the field of clinical development by working with a leading, early-phase clinical trial provider. About the Role: We are seeking an experienced and driven Senior Clinical Project Manager to lead and oversee the planning, execution, and delivery of complex early phase clinical trials. This role is ideal for someone with a strong background in managing both Phase 1 trials involving healthy participants and multi-centre studies across diverse geographies. Key Responsibilities: • Lead the end-to-end management of clinical trials, ensuring compliance with regulatory requirements and internal SOPs., • Oversee Phase 1 and 2a trials with healthy and patient participants, ensuring safety, ethical standards, and scientific integrity., • Manage multi-centre studies, coordinating across sites to ensure consistency and quality of data., • Lead and facilitate key meetings, including Site Initiation Visits (SIVs), progress meetings with Sponsors and vendors and safety review committee meetings ensuring clear communication, alignment of objectives, and timely resolution of any issues., • Develop and maintain project timelines, plans, budgets, and risk mitigation strategies., • Collaborate with cross-functional teams including clinical, medical writing, data management, and biostatistics., • Serve as the primary point of contact for sponsors, CROs, and site investigators., • Provide mentorship, training and guidance to junior clinical project managers., • Oversee external vendors, ensuring deliverables meet quality standards, timelines, and contractual obligations. Requirements: • Life sciences degree or equivalent., • Minimum of 5 years’ experience in clinical project management., • Proven track record managing early-phase trials with healthy participants., • Experience leading multi-centre patient studies, preferably in a global setting., • Strong knowledge of ICH-GCP and UK regulatory guidelines., • Excellent communication, leadership, and organisational skills., • Ability to work independently and manage multiple priorities. Desirable: • Higher degree, • Experience with electronic trial master files, • Experience of regulatory and ethics submissions in the UK using IRAS., • Knowledge of US regulations