Project Manager, Laboratory Services

This is a fully remote position, open to applicants in Ohio.

📋 Description

• Plan, execute, evaluate, and finalize assigned laboratory clinical trials/projects; may serve as a global lead when applicable.

• Expected to oversee trials of medium to high complexity.

• Establish objectives and timelines, provide guidance, and inspire the team to achieve goals within set timelines and with high-quality execution of assigned laboratory clinical trials/projects.

• Ensure oversight and coordination of the operational facets of the functional areas on assigned clinical trials/projects, ensuring compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), relevant regulatory guidelines, and laboratory protocols.

• Manage the entire scope of laboratory clinical trials/projects, including global clinical trials/projects from initiation through closure; oversee functionally assigned team members on laboratory clinical trials/projects; manage multiple clinical trials/projects concurrently.

• Collaborate closely with the CTI Clinical Project Manager and team members on full-service clinical trials/projects.

• Coordinate a laboratory clinical trial/project, including organization, implementation, and management of scoped activities.

• Prepare or supervise the development of project plans and timelines; collaborate with laboratory leadership and/or line manager to provide effective solutions to challenges that may arise during the laboratory clinical trial/project.

• Participate in or provide oversight and guidance in developing clinical trial/project-required deliverables.

• Act as Global Project Manager and/or client contact at the operational level of clinical trials/projects.

• Oversee contracted vendors; review contracted specifications while maintaining regular communication with vendors to ensure timelines and expectations are met.

• Ensure appropriate tracking of clinical trial/project activities using computer-assisted programs and verify timely entry of project information by all project team members to facilitate accurate reporting to clients and CTI executive management.

• Monitor ongoing resource requirements for the clinical trial/project; inform relevant functional department heads of any identified resource needs or performance issues.

• Ensure that the assigned clinical trial/project team receives necessary training to support effective implementation, conduct, and execution of the clinical trial/project.

• Collaborate with the client and cross-functional CTI laboratory departments to create the Laboratory Specifications Plan based on contracted services at the start of a new clinical trial/project, and maintain and update the document as required throughout the clinical trial/project lifecycle.

• Construct a clinical trial/project-specific laboratory database in the lab information management system (LIMS) at the initiation of a new clinical trial/project; maintain and update the database as necessary throughout the clinical trial/project lifecycle.

• Develop project-specific site tools such as the Laboratory Manual and Quick Reference Guides (if applicable); maintain and update these documents as needed throughout the clinical trial/project lifecycle.

• Collaborate 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 a liaison between logistics and data management to address sample-related issues.

• Implement project activities in accordance with the scope of contracted work.

• Coordinate the shipment of stored samples as directed by the scope of work and supporting documents, in collaboration with the client.

• Evaluate and manage the clinical trial/project budget against project milestones and scope; work with laboratory leadership to implement corrective measures when necessary to maintain alignment with the budget.

• Assess the scope of work against client contractual agreements and collaborate with laboratory leadership to facilitate change of scope orders when appropriate.

• Conduct client and team meetings to promote effective information sharing, discussion, and decision-making; ensure accurate documentation of meeting discussions, decisions, and outcomes.

• Prepare or oversee the 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.

• Recommend and engage in process improvement activities and initiatives.

⛳️ Requirements

• Exceptional verbal and written communication skills.

• Ability to cultivate strong customer service and collegial relationships with clients, peers, and other internal and external stakeholders; demonstrates effective interpersonal skills to provide positive leadership.

• Capability to manage assigned LPM responsibilities effectively.

• Strong organizational, record retention, and time management skills.

• Excellent decision-making and creative problem-solving abilities.

• Demonstrates critical thinking skills and the capacity to effectively manage shifting priorities.

• Comprehensive knowledge and clear understanding of CTI SOPs.

• Ability to clearly articulate the application and implications of LPM processes, SOPs, and related procedures.

• Proven ability to effectively manage conflict and facilitate problem-solving by proposing solutions.

• Demonstrates accountability and follow-through on all assigned projects.

• Proficient in the use of computer and software systems.

• Ability to understand, interpret, and explain medical details associated with assigned laboratory projects.

• Capacity to acquire and synthesize new knowledge and integrate this with current practices and associated risks to facilitate effective decision-making and planning.

• Ability to foster collaboration and coordination among a diverse group (disciplines, individuals, countries/cultures) to achieve desired objectives.

• Demonstrates knowledge and clear understanding of the drug development process.

• Strong understanding of ICH / Good Clinical Practice (GCP) guidelines and relevant regulatory requirements.

• Bachelor’s degree or equivalent, preferably in allied health fields such as nursing, pharmacy, medical technology, or health science.

🏝️ Benefits

• We support career advancement – We believe in promoting from within and have a structured mentoring program, along with a program for recent graduates to provide necessary support for employee progression.

• We value education and training – We offer tuition assistance, collaborate with universities and colleges to create relevant programs, and have a dedicated training department.

• We prioritize our people - We have never had a layoff in our three-decade history and ensured full pay for our employees during the COVID-19 shutdown, regardless of hours worked.

• We advocate for work-life balance and the significance of family time by offering generous vacation time, a hybrid work-from-home schedule, and paid parental leave.

• Our culture is unmatched – We have 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 a global presence while maintaining connections to local communities where we operate.

• Our CTI Cares Committees are committed to ensuring that CTI’s culture and values are reflected worldwide.

• We are focused on the future – We have consistently achieved a double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on an average annual retention rate of 95%, significantly higher than many other CROs.

• Our work has a meaningful impact – We concentrate our efforts on treatments for chronically and critically ill patients who depend on us to bring these life-changing therapies to market.