Laboratory Specialist

We 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 3000 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.Job Description1. Study related activities (Laboratory Support). Manages all laboratory related activities within a clinical study under supervision, including:Reviews laboratory-related study documentsProvides laboratory-related advice to PSI and Sponsor study teamsContributes to the development of diagnostic strategiesPresents laboratory strategy at kick-off meetingsSupports the selection for studiesPerforms assessments of off-site / on-site laboratories for a studyCoordinates the contracting of laboratory vendorsPerforms set up of laboratory vendorsContributes to Risk Management processProvides information to PSI Data Management (DM) to aid clinical rial database designDelivers training to the study team and/or clinical sites in laboratory related proceduresPerforms initiation and monitoring visits to laboratories as requiredCoordinates routine calls with central laboratoriesAttends study progress calls with the SponsorInvestigates issues with laboratoriesCoordinates the transfer of samples between laboratoriesAssists DM in on-going data reconciliationCoordinates any changes to the laboratory strategyPerforms close out of laboratories2. Quality Control & Quality Assurance:Participates in the development and/or implementation of operational (project specific and laboratory specific) quality control documentsParticipates in system audits and follows up on audit findings related to laboratories that provide testing for the assigned projectsQualificationsUniversity or college degree in Life Sciences requiredAn MD degree PhD degree is a plusAt least 2 years' experience working in a clinical laboratory settingPrior clinical research industry experience is a plusStrong communication and presentation skillsAttention to detail and organizational skills are criticalAbility to work in a team setting as well as independently as neededProficient in using Microsoft Office toolsAdditional InformationIf 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.