Job Details

Job Purpose/ Summary: The Clinical Project Manager III (CPM III) is responsible for execution and oversight of assigned clinical trials (Phase I through Phase IV) to ensure client's goals of time, cost, and quality performance are met. The CPM III is expected to be independent butmay require consultation and guidance from the trial-assigned Director to ensure successful clinical trial execution and to support other functional team members' management of daily trial operations. Often functions as a global lead to provide client interface and oversight of trial regions' operational activities. The CPM III is seen as skilled in the application of the essential functions of the CPM role listed below.

What You'll Do:

• Plan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial lead.
• Set goals, and timelines, provide oversight and positive leadership to foster motivation within the team to accomplish goals within defined timelines and with high quality in the execution of assigned clinical trials.
• Provide oversight and coordination of the operational aspects of the functional areas on assigned projects to ensure compliance with International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and trial procedures.
• Provide management of a full scope clinical trial projects including global trials from start-up through analysis phase; provide oversight of functionally assigned teams members on clinical trials projects; able to effectively manage multiple projects simultaneously.
• Provide coordination of a clinical trial project including organization, implementation, and management of scoped activities
• Implement project activities according to scope of contracted work.
• Evaluate and manage project budget against project milestones and scope and collaborate with the trial assigned Director as needed to take corrective measures where necessary to keep project in line with budget.
• Regularly assess project profit margins with trial-assigned Director at the project and project service levels and work with the trial-assigned Director and project team to understand deficiencies; support and mitigation strategies to positively impact project profit margins.
• Assess scope of work against client contractual agreement and inform trial assigned Director of any concerns; facilitate change of scope orders when appropriate.
• Prepare or provide oversight and support to the development of trial plans, timelines, schedules, resources, and budgets; work with team and trial assigned Director to provide effective solutions to challenges that arise during the clinical trial project.
• Prepare or provide oversight and guidance in the development of trial required deliverables.
• Serve as client contact at project operational level.
• Provide oversight to contracted vendors; review contracted specifications and maintain regular interactions with vendors to ensure meeting timelines and expectations. Provide oversight and management of third-party vendors' financial spend.
• Closely reviews and assesses trial's KPI to ensure project progressing in a positive manner and actively works with team to mitigate activities that are outside the expected ranges.
• Provide oversight of appropriate project tracking using computer-assisted programs and ensure timely entry of project information by all trial team members to enable accurate reporting to clients and CTI executive management.
• Monitor ongoing resource needs to the project; keep appropriate functional department heads apprised of any identified resource needs or performance issues.
• Ensure that the assigned clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocol.
• Provide oversight of Clinical Research Associate (CRA) tasks on assigned projects; provide oversight of the CRA's management of sites and monitoring of the clinical trial data; review and approve site trip reports and escalate site issues as needed to trial assigned Director, CTI executive management and/or client/sponsor in accordance with the trial's Project and Communication Plan
• Attend site visits on an as-needed basis to provide support to the trials, CTI staff and/or site staff.
• Lead client and team meetings to enable effective information sharing, discussion, and decision-making; ensure accurate and complete documentation of the meeting discussions, decisions and outcomes.
• Prepare or provide oversight/approval of project status reports for assigned projects.
• Participate and provide oversight in the planning of Investigator meetings; develop and/or approve meeting agendas or related materials and conducts presentations.
• Ensure completeness of the TMF through management and maintenance of the TMF for assigned studies ensuring that all trial assigned staff regularly submit documents and complete regular audits of the TMF to ensure accuracy and completeness as defined in the trial's TMF Plan.
• Participate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.).
• Suggest, participate in and/or lead process improvement activities and initiatives.
• Mentor other CPM staff.
• As required per region, review site and vendor invoices, approve subject milestones payments per scope; assist in the preparation of payment projections, and in the maintenance of payment records per regional needs. Support or conduct site budget negotiation for sites in their region as needed.

What You'll Bring:

• Bachelor's degree in allied health fields such as nursing, pharmacy, health or natural sciences, preferably with clinical trial management experience or an equivalent combination of education and relevant work experience
• At least 6 years of clinical research experience (CRO CRA or Research Manager, Site Research Manager, Central Clinical Research Laboratory Manager) or possesses transferrable skills and experience in project management in a clinical setting or relatable industry
• Graduate degree preferred
• Previous technical and managerial experience in conducting clinical pharmaceutical research studies in a hospital setting, a pharmaceutical company, or CRO.
• Previous CRA experience preferred
• Experience or education indicating knowledge of medical and pharmaceutical terminology preferred
• Previous experience in a Clinical Project Manager or Clinical Trial Manager level position preferred

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important NoteIn light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you directly via Microsoft Teams Messaging or by text message
• We will never ask for your bank account information at any point during the recruitment process

Equal Opportunity Employer/Veterans/Disabled

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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