Project Manager, Laboratory Services

🕒 Março 28

🏈 Ohio – Remoto

🏈 Ohio – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👷‍♀️ Gerente de Projetos

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CTI Clinical Trial and Consulting Services

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1999

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

CTI Clinical Trial and Consulting Services é uma organização de pesquisa por contrato (CRO) de serviço completo que fornece execução de ensaios clínicos, estratégia regulatória, serviços de laboratório e bioanalíticos, geração de evidências do mundo real e gestão de centros de pesquisa para patrocinadores de biotecnologia e farmacêuticos. Com expertise em estudos de Fase I a IV e áreas terapêuticas complexas (incluindo doenças raras, terapia celular e gênica, oncologia, neurologia e transplante), a CTI apoia o desenho de estudos, gestão de sites, recrutamento de pacientes, monitoramento, segurança/farmacovigilância, biometria e garantia de qualidade. Com sede em Covington, KY, a empresa enfatiza abordagens integradas e centradas no paciente e orientação regulatória global para acelerar o desenvolvimento e levar terapias aos pacientes.

Descrição

• 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 Global 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 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 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 initiatives

🎯 Requisitos

• 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.

🏖️ Benefícios

• We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward • We value education and training – We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department • We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. • We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. • Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry • We think globally and act locally – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. • Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. • We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs • Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market