Clinical Trial Manager

Clinical Trial ManagerGlobal Clinical OperationsRemote EU OpportunityThe Clinical Trial Manager will be responsible and accountable for the development of clinical trial operational strategy and leading planning execution of day-to-day study operations, leading the cross-functional Clinical Trial Team (CTT), managing outsourced Contract Research Organization (CRO) and third party vendor activities, and being accountable for adherence with overall clinical trial timelines, budget, quality, and regulatory standards (ICH/GCP, internal SOPs). ResponsibilitiesLeads efforts in study start-up including study feasibility, site selection, preparation and follow-up of site regulatory packages in collaboration with the CRO and cross-functional team.Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriateMay contribute to development of clinical outsourcing specifications to facilitate bid process and selection of Contract Research Organizations (CROs); manages interface with CROs in cooperation with line functions; ensures vendors meet quality standards in their work for the trial; contributes to the development/amendment of vendor contracts.Acts as initial point of contact for all site-related issues and procedural questions.Oversee and manage the activities outsourced to the CRO/vendor throughout the entire duration of the trial, in accordance with the Clinical Trial Oversight Plan.Core member of the global cross-functional Clinical Trial Team (CTT); reports study progress and issues/resolution plan at the CTT meeting; writes CTT meeting minutes. Organizes and chairs trial sub teams within the scope of his/her delegated responsibilities.Defines the Data Review Plan with the support of the team; ensure clinical trial data is cleaned to ensure scientific excellence.Manages study-specific vendors, as appropriate.Supports the Clinical Program Lead with the development, management and tracking of the trial level budget including forecast, and annual budget reviews.May organize and logistics of various trial advisory committees (e.g. Data Monitoring Committee, Steering Committee).Manages relationships to ensure successful delivery of all study life cycle deliverables (RFP through completion of the trial).Ensures that the electronic Trial Master File (eTMF) is maintained appropriately throughout the trial, including periodic reviews.Contributes to operational excellence through process improvement and knowledge sharing.Participates and supports response to Quality Assurance and/or regulatory authority inspection audits.Ability to collaborate with other departments to meet study timelines and goals.Provides guidance and mentorship to the Associate Clinical Trial Manager (CTM) and Clinical Trial Assistant (CTA).Supports departmental functions and attends departmental meetings. Skills/KnowledgeBA/BS or equivalent degree in relevant discipline (scientific background is preferred).Minimum of 2-3 (Associate CTM) and 3-4 years (CTM) of experience in clinical research with a sponsor company or CRO (oncology experience strongly preferred).Understanding of clinical development within one or more Phases of trials (Phase I, II, and III).Scientific learning agility to quickly develop a sound working knowledge of the therapeutic area.Requires minimal supervision to manage various activities associated with multiple clinical studies in accordance with designated project assignments.Understanding of basic biological principles in oncology required.Excellent knowledge on ICH/GCP, FDA-CFR.Able to communicate effectively. Menarini Stemline is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.