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Study Start-Up Managers Eu Ctr V-094

Detalles de la oferta

.Study Start-Up Managers EU CTRLocations: Across Europe where we have a Site Management & Monitoring (SMM) presenceCompetitive salary and benefitsMake a more meaningful impact on patients' lives around the globe. Here you'll have the opportunity to make a meaningful difference to patients' lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines - for the world's most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem. Join the team that follows the science unlike anywhere else. This is the place for curious minds.Typical accountabilities:Management, coordination, and collation of Part 2 packagesAttend the global submission planning kick-off meeting(s)Agree on timeline planning for submission with global and local teamsEnsure local teams are fully aware of submission timelines to allow robust SQV's / site selection visits to occur with EU/EEA sitesEnsure global documents are provided to local teams in time for Part 2 package preparation. Hold global team accountable for deliveryCollate Part 2 submission Table of Content (ToC) and corresponding part 2 documents completed by local study associate directorsReach out to the countries to ensure ToC reflects the country submission documents and meets the EU CTR requirementsCheck completeness, not content, of Part 2 submission packages (downloaded documents) with ToCHold EU/EEA local teams accountable to the delivery of the part 2 package to the agreed timelinesProvide support to local teams on EU CTR specific questions and document contentCoordinate Part 2 RFI responses and ensure agreement between local teams and global teams on translations as required (CTIS fields, CSP synopsis, cover letter etc


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Fuente: Jobtome_Ppc

Requisitos

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