.Start up Lead/Senior Start up Lead - Clinical Trial Services Remote RomaniaJob Type: regular full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 4478Precision for Medicine (CRO) is hiring an experienced Start up Lead/Senior Start up Lead who has a passion for site start up to join our team. Candidates can be based in the following countries: Spain, UK, Hungary, Slovakia, Serbia, Romania, or Poland.Position Summary:The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. The SU Lead will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs, or others) supporting site start-up activities, Trainer for less-experienced staff, and may be identified as Owner of country-specific tools and guidance documents to increase knowledge share of country-specific site start-up activities.Essential functions of the job include but are not limited to:Manage the site start-up process through development of an activation readiness strategy to enable oversight of site start-up delivery.Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start-up activities to allow on-time activation.Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start-up.Partner closely with Functional Leaders and Site Start-up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real-time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.Responsible for coordinating translations for documents required for submissions.Maintain communication with other key functions participating in country start-up, i.E., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project-specific status and deliverables.Act as SME for collection and maintenance of site-level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts, and budget negotiation requirements that may be in place as well as other start-up requirements for assigned country
