Project Manager, Laboratory Services

Plan, implement, evaluate, and complete execution of assigned laboratory clinical trials/projects; may function as a global lead, where applicable.
Expected to manage medium to high complexity trials.Set goals and timelines, provide oversight and foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned laboratory clinical trials/projectsProvide oversight and coordination of the operational aspects of the functional areas on assigned clinical trials/projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines, and laboratory proceduresProvide management of the full scope of laboratory clinical trials/projects including global clinical trials/projects from start-up through closeout; provide oversight of functionally assigned teams members on laboratory clinical trials/projects; manage multiple clinical trials/projects simultaneouslyWork closely with the CTI Clinical Project Manager and Team members on full service clinical trials/projectsProvide coordination of a laboratory clinical trial/project including organization, implementation, and management of scoped activitiesPrepare or provide oversight to the development of project plans and timelines; work with laboratory leadership and/or line manager to provide effective solutions to challenges that arise during the laboratory clinical trial/projectParticipate in or provide oversight and guidance in the development of clinical trial/project required deliverablesServe as Global Project Manager and/or client contact at clinical trial/project operational levelProvide oversight to contracted vendors; review contracted specifications and maintains regular interactions with vendors to ensure meeting timelines and expectationsProvide oversight of appropriate clinical trial/project tracking using computer-assisted programs and ensure timely entry of project information by all project team members to enable accurate reporting to clients and CTI executive managementMonitor ongoing resource needs to the clinical trial/project; keep appropriate functional department heads apprised of any identified resource needs or performance issuesEnsure that assigned clinical trial/project team receives appropriate training as needed to facilitate effective implementation, conduct and execution of the clinical trial/projectIn conjunction with the client and cross?functional CTI laboratory departments, create the Laboratory Specifications Plan based upon contracted services at the initiation of a new clinical trial/project, and maintain and update the document as needed throughout the lifecycle of the clinical trial/projectBuild clinical trial/project?specific laboratory database in lab information management system (LIMS) at initiation of a new clinical trial/project; maintain and update thedatabase as needed throughout the lifecycle of the clinical trial/project.Develop project?specific site tools such as the Laboratory Manual and Quick Reference Guides (if applicable); maintain and update these documents as applicable throughout the lifecycle of the clinical trial/projectWork with cross?functional CTI laboratory departments to design clinical trial/project?specific tools and supplies such as sample requisition forms, sample labels, and lab kitsServe as liaison between logistics and data management to resolve issues with samplesImplement project activities according to scope of contracted workCoordinate shipment of stored samples as directed by the scope of work and supporting documents, in conjunction with the clientEvaluate and manage clinical trial/project budget against project milestones and scope; work with laboratory leadership to take corrective measures where necessary to keep clinical trial/project in line with budgetAssess scope of work against client contractual agreements and works with laboratory leadership to facilitate change of scope orders when appropriateLead client and team meetings to enable effective information sharing, discussion and decision?making; ensures accurate and complete documentation of the meeting discussions, decisions and outcomesPrepare or provide oversight/approval of weekly and/or monthly clinical trial/project status reports for assigned projectsParticipate and contribute to site training meetings, such as Investigator meetings or site initiation visitsSuggest and participate in process improvement activities and initiativesWhat You'll BringExcellent verbal and written communication skillsAbility to foster strong customer service and collegial relationships with clients, peers and other internal and external customers; demonstrates effective interpersonal skills to provide positive leadershipAbility to manage assigned LPM responsibilitiesExcellent organizational, record retention and time management skillsExcellent decision?making and creative problem?solving skillsDemonstrates critical thinking skills and ability to effectively manage shifting prioritiesDemonstrates strong knowledge and clear understanding of CTI SOPsAbility to clearly articulate the application and implications of LPM processes, SOPs and related proceduresDemonstrates ability to effectively manage conflict and facilitate problem solving by offering solutionsDemonstrates accountability and follow through on all assigned projectsProficient use of computer and software systemsAbility to understand, interpret, and explain medical details associated with assigned laboratory projectsAbility to acquire and synthesize new knowledge and assimilate this with current practices and possible associated risks to foster effective decision making and planningAbility to foster collaboration and coordination amongst a diverse group (disciplines, individuals, countries/cultures) to achieve desired goalsDemonstrates knowledge and clear understanding of the drug development processDemonstrates strong knowledge and clear understanding of ICH / Good Clinical Practice (GCP) guidelines and applicable regulatory requirementsBachelor's degree or equivalent, preferably in allied health fields such as nursing, pharmacy, medical technology, or health scienceAbout CTIAdvance Your CareerWeinvestinyourprofessionalgrowth.Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.Wealsoencourageongoingeducationtohelpyouachieveyourprofessionalgoals.JoinanAward-WinningTeam –Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople.Wesupportyourwork-lifebalancewithhybridworkopportunities.ThroughourCTICaresprogram,you'llhaveopportunitiestogivebacktoyourcommunityandtheworld.MakeaLastingImpactAtCTI,yourworkdirectlycontributestoadvancingmedicine.You'llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses.Together,wemovemedicineforward,makingadifferenceforthosewhoneeditmost.Important NoteInlightofrecentincreaseinhiringscams,ifyou'reselectedtomoveontothenextphaseofourhiringprocess,amemberofourteamwillreachouttoyoudirectlyfroman @ctifacts.Com emailaddresstoguideyouthroughourinterviewprocess.Pleaseensureyouareapplyingforjobsdirectlyonourwebsite( )orfromourverifiedLinkedInpage.Please NoteWewillnevercommunicatewithyouviaMicrosoftTeamsortextmessageWewillneveraskforyourbankaccountinformationatanypointduringtherecruitmentprocess#J-*****-Ljbffr