Study Startup Specialist II

Company DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.Job DescriptionTake your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time. You will:Perform study startup activities and support all processes critical for site activationCollect site documents for IRB/IEC submission and/or IP-RED processFile study-specific documentation in TMF, in accordance with Document management planAssist in feasibility research and site identification, upon requestFacilitate site agreement and budget negotiationsCoordinate translation and review of study-specific documentsIdentify and escalate project-specific issues as neededPrepare and submit IP-REDs packagesEnsure initial distribution of locally obtained clinical study supplies to sites and supervises initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sitesEnsure exchange of information and documentation with investigational sites, off site facilities and vendorsParticipate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets under supervisionQualificationsCollege/University degree in Life Sciences or an equivalent combination of education, training and experienceAt least 2 years of full-scope Study Startup experience in the country/regionFull working proficiency in EnglishWell-developed communication and organizational skillsAbility to negotiate and build relationships at all levelsAdditional InformationWe offer:Excellent working conditionsExtensive training and friendly teamCompetitive salary and benefits packageOpportunities for personal and professional growthMake the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.SummaryType: Full-timeFunction: OtherExperience level: AssociateIndustry: Pharmaceuticals