Project Manager, Laboratory Services

Location: Gasteiz / Vitoria

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 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

What 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…