Clinical Project Manager III – Senior
CTI Clinical Trial and Consulting Services
full-time
Posted on:
Location Type: Remote
Location: Kentucky • United States
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About the role
- 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
- 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
- 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
- Ensure that the assigned clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocol
- 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
Requirements
- 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
Benefits
- We support career progression through a structured mentoring program and leadership courses
- Ongoing education and training through tuition reimbursement and a dedicated training department
- Generous health benefits and vacation packages
- Hybrid work from home opportunities
- Paid parental leave
- CTI Cares program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementproject managementbudget managementKPI assessmentclinical researchclinical pharmaceutical researchtrial planningregulatory complianceGood Clinical Practices (GCP)International Council for Harmonization (ICH)
Soft Skills
leadershipteam motivationcommunicationorganizational skillsproblem-solvingoversightcollaborationdecision-makingtrainingclient management