Study Startup Specialist II

Study Startup Specialist IIFull-timeCompany 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.This is an office-based position from our Bangalore office.You will:Collaborate with the project team for site activation processesFacilitate site agreement, contract negotiations and budget negotiationsCollect site documents for IRB/IEC submission and/or IP-RED processCoordinate translation and review of study-specific documentsIdentify and escalate project-specific issues as neededPrepare and submit the study dossiers to sites, competent authorities, IRBs/IECsPrepare IP-REDs packagesSupport initial distribution of Investigational Product(s) and 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 targetsQualificationsCollege/University degree in Life Sciences or an equivalent combination of education, training and experienceAt least 2 years of full-scope Study Startup experience in India-based trialsFull professional working proficiency in EnglishWell-developed communication and organizational skillsAbility to negotiate and build relationships at all levelsAble to commute to our Bangalore office dailyAdditional 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.By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyI'm interestedI'm interestedPrivacy Notice