- 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/projects- Provide 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- Provide 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 simultaneously- Work closely with the CTI Clinical Project Manager and Team members on full service clinical trials/projects- Provide coordination of a laboratory clinical trial/project including organization, implementation, and management of scoped activities- Prepare 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- Participate in or provide oversight and guidance in the development of clinical trial/project required deliverables- Serve as Integral Project Manager and/or client contact at clinical trial/project operational level- Provide oversight to contracted vendors; review contracted specifications and maintains regular interactions with vendors to ensure meeting timelines and expectations- Provide 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- Monitor ongoing resource needs to the clinical trial/project; keep appropriate functional department heads apprised of any identified resource needs or performance issues- Ensure that assigned clinical trial/project team receives appropriate training as needed to facilitate effective implementation, conduct and execution of the clinical trial/project- In 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- Build 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/project- Work 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- Serve as liaison between logistics and data management to resolve issues with samples- Implement project activities according to scope of contracted work- Coordinate shipment of stored samples as directed by the scope of work and supporting documents, in conjunction with the client- Evaluate 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- Assess scope of work against client contractual agreements and works with laboratory leadership to facilitate change of scope orders when appropriate- Lead 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- Prepare or provide oversight/approval of weekly and/or monthly clinical trial/project status reports for assigned projects- Participate and contribute to site training meetings, such as Investigator meetings or site initiation visits- Suggest and participate in process improvement activities and initiativesWhat You'll Bring- Excellent verbal and written communication skills- Ability 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- Ability to manage assigned LPM responsibilities- Excellent organizational, record retention and time management skills- Excellent decision‑making and creative problem‑solving skills- Demonstrates critical thinking skills and ability to effectively manage shifting priorities- Demonstrates strong knowledge and clear understanding of CTI SOPs- Ability to clearly articulate the application and implications of LPM processes, SOPs and related procedures- Demonstrates ability to effectively manage conflict and facilitate problem solving by offering solutions- Demonstrates accountability and follow through on all assigned projects- Proficient use of computer and software systems- Ability to understand, interpret, and explain medical details associated with assigned laboratory projects- Ability to acquire and synthesize new knowledge and assimilate this with current practices and possible associated risks to foster effective decision making and planning- Ability to foster collaboration and coordination amongst a diverse group (disciplines, individuals, countries/cultures) to achieve desired goals- Demonstrates knowledge and clear understanding of the drug development process- Demonstrates strong knowledge and clear understanding of ICH / Good Clinical Practice (GCP) guidelines and applicable regulatory requirements- Bachelor’s degree or equivalent, preferably in allied health fields such as nursing, pharmacy, medical technology, or health scienceAbout CTI- Advance Your CareerWeinvestinyourprofessionalgrowth.Ourstructuredmentoringprogram,leadershipdevelopmentcourses,anddedicatedtrainingdepartmentprovidethesupportyouneedtoexcel.Wealsoencourageongoingeducationtohelpyouachiev - JoinanAward-WinningTeam–Joinaglobalteamspanning60countries,recognizedforitsaward-winningculturethatprioritizespeople.Wesupportyourwork-lifebalancewithhybridworkopportunities.ThroughourCTICaresprogram, - MakeaLastingImpactAtCTI,yourworkdirectlycontributestoadvancingmedicine.You’llplayavitalroleindevelopinglife-changingtreatmentsforpatientswithchronicandcriticalillnesses.Together,wemovemedicineforward,makingadifferencef Important NoteInlightofrecentincreaseinhiringscams,ifyou'reselectedtomoveontothenextphaseofourhiringprocess,amemberofourteamwillreachouttoyoudirectlyfroman@ctifacts.comemailaddresstoguideyouthroughourinterviewproce )orfromourverifiedLinkedInpage.Please Note- WewillnevercommunicatewithyouviaMicrosoftTeamsortextmessage- Wewillneveraskforyourbankaccountinformationatanypointduringtherecruitmentprocess#J-18808-Ljbffr

📌 Project Manager, Laboratory Services (San Sebastián)
🏢 Consulting
📍 San Sebastián