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.
• 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.
• Manage 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.
• 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.
• Provide oversight to contracted vendors; review contracted specifications and maintain regular interactions with vendors to ensure meeting timelines and expectations.
• Oversee 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.
• Maintain 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.
• Create the Laboratory Specifications Plan based upon contracted services at the initiation of a new clinical trial/project; maintain and update the document as needed throughout the lifecycle of the clinical trial/project.
• Develop 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.
• Serve as liaison between logistics and data management to resolve issues with samples.
• 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.
• Absess 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 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.
• 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.
• Clearly articulates 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.
• Understand, interpret, and explain medical details associated with assigned laboratory projects.
• Acquire and synthesize new knowledge and assimilate this with current practices and possible associated risks to foster effective decision making and planning.
• 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.