Project Manager, Laboratory Services - Level Dependent on Experience

CTI Clinical Trial and Consulting Services•Covington, KY

10h•Hybrid

About The Position

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

Requirements

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

Responsibilities

Plan, implement, evaluate, and complete execution of assigned laboratory clinical trials/projects; may function as a global lead, where applicable.
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