What will I be doing? Were looking for two Clinical Study Managers to join the team and lead the multidisciplinary clinical study teams to ensure all clinical trial deliverables are met. Key duties include: Ensure all trial deliverables are met according to timelines, budget, operational best practices and compliance with policies, the EU Directive and ICH GCP guidelines To define and agree the study timelines and milestones in conjunction with the study team for their inclusion into the overall project plan To write and drive the preparation and review of the clinical study protocol and other study essential documents, according to the relevant SOPs To identify and assess potential trial sites with relevant members of the study team and decide on suitable sites for the study. To negotiate agreements with NHS trusts, including the negotiation of clinical trial costs To chair and facilitate study meetings with the internal teams, investigators and other key stakeholders and actively manage team actions, track study progress, and regularly communicate study progress to study team, Project Leader, Senior Research Manager and others as appropriate. To interact with Investigator sites and the study team to ensure excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised To liaise with the Medical Writing team for the delivery of the clinical study reports To identify best practices, lead or contribute to continual improvement initiatives and implement new procedures for managing clinical studies What skills are we looking for? Biological Sciences degree or equivalent nursing qualification/experience Experience of coordinating clinical studies or monitoring them (preferably including early phase oncology) evidence of successful adherence to study timelines and an understanding of key issues surrounding trial management Strong interpersonal skills with the ability to inspire effective teamwork and motivate members within a matrix system. Resolves conflict as needed. Outstanding knowledge of ICH GCP, the UK clinical trial environment, drug development process and early phase clinical trials relevant to the pharmaceutical/biotech industry Significant experience in project planning and the tools used to do it Excellent writing skills to enable drafting and creation of SOPs, protocols, NHS trust agreements and other relevant documents. Strong negotiation skills to enable negotiation of costs and contracts Please apply on the Lifelancer platform at the below link for screening steps & quicker response. https://lifelancer.com/jobs/view/2c543a937c098e049ae9e51737c2184c