pJoin us in redefining what it means to work for a CRO. /ppWhen you work at Rho, it's more than just a job—you become part of the Rho Factor. We're a proud bunch of science nerds who love tackling big challenges together. We're not your typical CRO, and we're not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do. /ppWhether you're a data wizard, analytical genius, project mastermind, or any other role, you'll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other. /ppYou'll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. /ppThis is your opportunity to join Rho as a bStudy Start Up Lead /b - we are open to this role being located in Italy, Spain, Poland, Latvia, Lithuania or Bulgaria. This is a remote opportunity. /ph3Responsibilities /h3ulliManage the study start up process through site activation, working with Project Manager and Clinical Trial Lead to ensure timely site activations /liliParticipate in Sponsor meetings with respect to study start up, including endorsement of the SSU Operational Targets mitigation of delivery risks, establishing client expectations for delivery, communication, reporting,



and metrics /liliPartner closely with both Functional Leads and SSU Team Members to proactively identify study start up related issues /liliEnsure that relevant systems are maintained and up to date to analyze study start-up progress metrics against targets/timelines (at a project/country/site level) /liliProvide operational oversight to SSU Associates on assigned projects /liliResponsible for all submissions and obtaining approval from IRB/ECs (incl CTIS Part 2 package); /liliMay be responsible for submissions to Regulatory Authorities in non-EU countries (ex. UK, Georgia, South Africa etc) /liliCoordinate feasibility efforts and work together with Clinical Team Leads on site identification /liliIdentify the Site Essential Document (SED) packet elements required, agree with relevant internal staff, track the completion and upload of documents, and communicate with all parties (e.g., Sponsor, Site Staff, Internal Staff) the status of documents; participate as the SED Reviewer as necessary /liliCoordinate and develop the Start Up approach for IRB/EC approval at specified regional levels, including country level approval, and provide oversight of specific activities from SSU Team Members /liliPartner with Clinical Team Leads and the client to identify requirements for the Site Initiation Visit (SIV) and Site Activation /liliCoordinate the informed consent form (ICF) development, including the review,



negotiation and approval with relevant internal and external parties /liliSupport business development with proposal preparation and review and bid defense efforts /liliCoordinate site budget development, including the review, negotiation and approval with relevant internal and external parties. /liliCoordinate site contract negotiation process /liliDevelop country/site-specific startup timelines and strategies and oversee startup activities in the country /liliFacilitate cooperation between cross-functional teams regarding startup activities /li /ulh3Requirements /h3ulliAt least 4 years of industry experience, including 2+ years of study start up leading experience or equivalent /liliDemonstrated ability in the leadership of a team of individuals in study start-up /liliKnowledge of applicable international regulatory requirements and guidelines (i.e., ICH-GCP, and/ or EU-Directives) /liliStrong knowledge of Regulatory and Central/Local ethic submission processes for assigned countries /liliStrategic and creative risk management and contingency planning /liliStrong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members /liliExcellent organizational and interpersonal skills /liliStrategic and tactical thinking skills /liliClient-focused action-oriented approach to work /liliAbility to work independently, prioritize and work with a matrix team environment is essential /liliPositive attitude and ability to interact with all levels of staff to coordinate and execute study activities /liliStrong presentation skills /liliGlobal start up experience is preferred /liliProficient computer and internet skills, including working knowledge of MS-office applications, such as MS Outlook, Word and Excel /liliExpected required travel 10% on average /li /ul #J-18808-Ljbffr

📌 Study Start Up Lead (Italia)
🏢 Rho
📍 Italia