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 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 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

Why CTI?

At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.

For that reason, we treat our team members with the respect they deserve, and our numbers show it:

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

Project Manager, Laboratory Services - Level Dependent on Experience at CTI Clinical Trial and Consulting Services

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