Assoc Lab Project Set-Up Manager
CurrentResponsible for designing and launching studies, managing sponsor/CRO activities, accountability and ownership for the quality of all start-up work and sponsor deliverables. Key functions include database design, collaboration on project timelines, risk management, and mentoring junior staff. Adherence to ICH E6 guidelines.● Develop database design requirements, including configuration definitions for full protocols, protocol amendments, and sponsor study changes.● Maintain client design standards in accordance with the Clinical Protocol.● Manage study database configuration and serve as a point of contact for internal and external stakeholders during set-up.● Collaborate with colleagues during planning meetings, addressing project timelines and issues related to data management, logistics, clinical trial materials, laboratory testing, and specimen management.● Responsible for updating project documentation, including action/issues logs, status sheets, and timelines during the startup phase.● Proactively manage changes in study-related project scope, identify potential risks, and devise contingency plans.● Prepare and present study-specific materials at Investigator and Kick-off meetings. Participate in external and internal audits as required.● Provide day-to-day guidance to junior staff, acting as a mentor. Participate in improvement projects defined by the relevant process improvement management team.● Work performed in accordance with ICH E6 Guideline for Good Clinical Practice.
