Project Manager, Laboratory Services
CTI Clinical Trial and Consulting Services
full-time
Posted on:
Location Type: Remote
Location: Kentucky • Ohio • United States
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About the role
- 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.
Benefits
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trials managementproject managementbudget managementlaboratory database managementclinical trial trackingdata managementsample requisitionLIMSproject planningresource management
Soft Skills
communication skillsinterpersonal skillsorganizational skillstime managementdecision-makingproblem-solvingcritical thinkingconflict managementcollaborationleadership