pul liPlan, 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. /li liSet 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/projects /li liProvide 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 procedures /li liProvide management of the full scope of laboratory clinical trials/projects including general 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 simultaneously /li liWork closely with the CTI Clinical Project Manager and Team members on full service clinical trials/projects /li liProvide coordination of a laboratory clinical trial/project including organization, implementation, and management of scoped activities /li liPrepare 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/project /li liParticipate in or provide oversight and guidance in the development of clinical trial/project required deliverables /li liServe as Global Project Manager and/or client contact at clinical trial/project operational level /li liProvide oversight to contracted vendors; review contracted specifications and maintains regular interactions with vendors to ensure meeting timelines and expectations /li liProvide 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 management /li liMonitor ongoing resource needs to the clinical trial/project; keep appropriate functional department heads apprised of any identified resource needs or performance issues /li liEnsure that assigned clinical trial/project team receives appropriate training as needed to facilitate effective implementation, conduct and execution of the clinical trial/project /li liIn 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/project /li liBuild clinical trial/project‑specific laboratory database in lab information management system (LIMS) at initiation of a new clinical trial/project; maintain and update the database as needed throughout the lifecycle of the clinical trial/project. /li liDevelop 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/project /li liWork with cross‑functional CTI laboratory departments to design clinical trial/project‑specific tools and supplies such as sample requisition forms, sample labels, and lab kits /li liServe as liaison between logistics and data management to resolve issues with samples /li liImplement project activities according to scope of contracted work /li liCoordinate shipment of stored samples as directed by the scope of work and supporting documents, in conjunction with the client /li liEvaluate 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 budget /li liAssess scope of work against client contractual agreements and works with laboratory leadership to facilitate change of scope orders when appropriate /li liLead client and team meetings to enable effective information sharing, discussion and decision‑making; ensures accurate and complete documentation of the meeting discussions, decisions and outcomes /li liPrepare or provide oversight/approval of weekly and/or monthly clinical trial/project status reports for assigned projects /li liParticipate and contribute to site training meetings, such as Investigator meetings or site initiation visits /li liSuggest and participate in process improvement activities and initiatives /li /ul h3What You'll Bring /h3 ul liExcellent verbal and written communication skills /li liAbility to foster strong customer service and collegial relationships with clients, peers and other internal and external customers; demonstrates effective interpersonal skills to provide positive leadership /li liAbility to manage assigned LPM responsibilities /li liExcellent organizational,
record retention and time management skills /li liExcellent decision‑making and creative problem‑solving skills /li liDemonstrates critical thinking skills and ability to effectively manage shifting priorities /li liDemonstrates strong knowledge and clear understanding of CTI SOPs /li liAbility to clearly articulate the application and implications of LPM processes, SOPs and related procedures /li liDemonstrates ability to effectively manage conflict and facilitate problem solving by offering solutions /li liDemonstrates accountability and follow through on all assigned projects /li liProficient use of computer and software systems /li liAbility to understand, interpret, and explain medical details associated with assigned laboratory projects /li liAbility to acquire and synthesize new knowledge and assimilate this with current practices and possible associated risks to foster effective decision making and planning /li liAbility to foster collaboration and coordination amongst a diverse group (disciplines, individuals, countries/cultures) to achieve desired goals /li liDemonstrates knowledge and clear understanding of the drug development process /li liDemonstrates strong knowledge and clear understanding of ICH / Good Clinical Practice (GCP) guidelines and applicable regulatory requirements /li liBachelor’s degree or equivalent, preferably in allied health fields such as nursing, pharmacy, medical technology, or health science /li /ul h3About CTI /h3 ul libAdvance Your Career /b /li /ul pWeinvestinyourprofessionalgrowth.Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.Wealsoencourageongoingeducationtohelpyouachieveyourprofessionalgoals. /p ul libJoinanAward-WinningTeam /b–Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople.Wesupportyourwork-lifebalancewithhybridworkopportunities.ThroughourCTICaresprogram,you’llhaveopportunitiestogivebacktoyourcommunityandtheworld. /li libMakeaLastingImpact /b /li /ul pAtCTI,yourworkdirectlycontributestoadvancingmedicine.You’llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses.Together,wemovemedicineforward,makingadifferenceforthosewhoneeditmost. /p h3Important Note /h3 pInlightofrecentincreaseinhiringscams,ifyou'reselectedtomoveontothenextphaseofourhiringprocess,
[email protected] /bemailaddresstoguideyouthroughourinterviewprocess.Pleaseensureyouareapplyingforjobsdirectlyonourwebsite( )orfromourverifiedLinkedInpage. /p h3Please Note /h3 ul liWewillnevercommunicatewithyouviaMicrosoftTeamsortextmessage /li liWewillneveraskforyourbankaccountinformationatanypointduringtherecruitmentprocess /li /ul /p #J-18808-Ljbffr
📌 Project Manager, Laboratory Services (País Vasco)
🏢 Consulting
📍 País Vasco