Clinical Project Manager II​/III

Join to apply for the Clinical Project Manager II/ III role at CTI Clinical Trial and Consulting Services

Join to apply for the Clinical Project Manager II/ III role at CTI Clinical Trial and Consulting Services

Direct message the job poster from CTI Clinical Trial and Consulting Services

What You'll Do:

• Plan, implement, evaluate, and complete full execution of assigned clinical trials; may function 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 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 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; work with the trial-assigned Director 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 agreements and works with trial-assigned Director to facilitate change of scope orders when appropriate.
• Prepare or provide oversight and support to the development of trial plans and timelines; work with the trial-assigned Director or line manager to provide effective solutions to challenges that arise during the clinical trial project.
• Participate in 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 maintains regular interactions with vendors to ensure meeting timelines and expectations. Provide oversight and management of third-party vendors’ financial spend.
• With support of assigned trial director, 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 assigned clinical trial team receives appropriate trial training to facilitate effective implementation, conduct and execution of the protocol.
• Provide day-to-day 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 trial, 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…