Senior Manager, Clinical Trial Management (Pozuelo de Alarcón)
1 day ago
Pozuelo de Alarcón
Senior Manager, Clinical Trial Management • Act as the Functional Lead from Clinical Research Services with responsibility for delivery of all clinical aspects of clinical studies., • Oversee and serve as the liaison between the Project Manager and a group of Clinical Research Associates (CRAs) assigned to a given clinical study for the delivery of all aspects of monitoring and site management, ensuring consistency with ICH/GCP and applicable ICON Standard Operating Procedures (SOPs), applicable regulations, and the Monitoring Plan., • Ensure the clinical portion of the study is inspection ready at all times., • May act as a single service project manager, or as a project manager for small studies., • Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders; may also act as the primary point of contact for smaller or single service projects., • Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget, e.g. implementation of protocol and amendments, protocol deviation prevention, tracking and reporting, IP management, timely investigator payments., • Responsible for driving enrollment as per contracted timelines., • Regular oversight of key clinical metrics, including but not limited to Days on Site (DOS), Monitoring Visit reports (MVR) and Follow up Letters (FUL) timelines, Action Items (Al) and other quality metrics, ensuring they are met and followed-up as necessary., • Oversight of visit report review and approval, including site issue escalation and resolution; may involve direct review/approval of site visit reports and interactions with the Central Visit Report Approvers, as appropriate., • Ensure clinical data is entered into the ICON CTMS or any other CTMS in a timely and accurate manner., • Contribute to the development and maintenance of all clinical elements of cross-functional project plans., • Be able to work on multinational studies or take the role of a General CTM., • Responsible for coordinating, managing and mentoring the clinical project team to ensure high performance and productivity, optimal utilization, continuous development, minimal turnover, and that all necessary project training is provided, documented and filed appropriately., • Active involvement in clinical risk planning and assessment, developing mitigation strategies and associated action plans, issue escalation and resolution., • Responsible for the development and maintenance of operational plans for clinical deliverables, e.g. CRF completion guideline, Monitoring Plan, Recruitment Plan, Clinical Training Plan, annotated trip report, etc., • Ensure the core clinical portions of the Trial Master File (electronic or paper TMF) are up-to-date and maintained in accordance with SOPs and the File Master Plan (FMP), including involvement in archiving as necessary and documented QC checks of in-house investigator site files., • Ensure all close-out activities are completed as necessary, e.g. End of Trial (EOT) notifications sent, all payments made, CTMS updated, all visit reports finalized and all action items resolved., • Travel approximately 25% domestically and/or internationally. #J-18808-Ljbffr