Project Manager, Laboratory Services - Level Dependent on Experience

What You’ll Do 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 team 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 Global Project Manager and/or client contact at clinical trial/project operational level. Provide oversight to contracted vendors; review contracted specifications and maintain 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 for 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 the database 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 work 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; ensure 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 initiatives. What You 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 science. #J-18808-Ljbffr CTI Clinical Trial and Consulting Services