[Remote] Clinical Project Manager III/ Senior (level dependent on experience)

Note: The job is a remote job and is open to candidates in USA. CTI Clinical Trial and Consulting Services is a global, full-service clinical contract research organization focused on advancing treatments for chronically and critically ill patients. They are seeking a Clinical Project Manager III/Senior to oversee and execute clinical trials, ensuring compliance with guidelines while managing project timelines, budgets, and team coordination.ResponsibilitiesPlan, implement, evaluate, and complete full execution of assigned clinical trials; often functions as a global trial leadSet 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 trialsProvide 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 proceduresProvide 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 simultaneouslyProvide coordination of a clinical trial project including organization, implementation, and management of scoped activitiesImplement project activities according to scope of contracted workEvaluate 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 budgetRegularly 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 marginsAssess scope of work against client contractual agreement and inform trial assigned Director of any concerns; facilitate change of scope orders when appropriatePrepare 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 projectPrepare or provide oversight and guidance in the development of trial required deliverablesServe as client contact at project operational levelProvide 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 spendClosely 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 rangesProvide 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 managementMonitor ongoing resource needs to the project; keep appropriate functional department heads apprised of any identified resource needs or performance issuesEnsure that the assigned clinical trial team receives appropriate training to facilitate effective implementation, conduct and execution of the protocolProvide 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 PlanAttend site visits on an as-needed basis to provide support to the trials, CTI staff and/or site staffLead client and team meetings to enable effective information sharing, discussion, and decision-making; ensure accurate and complete documentation of the meeting discussions, decisions and outcomesPrepare or provide oversight/approval of project status reports for assigned projectsParticipate and provide oversight in the planning of Investigator meetings; develop and/or approve meeting agendas or related materials and conducts presentationsEnsure 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 PlanParticipate in business development activities as requested (RFP development, bid defense presentations, client meetings etc.)Suggest, participate in and/or lead process improvement activities and initiativesMentor other CPM staffAs 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 neededSkillsBachelor'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 experienceAt 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 industryGraduate degree preferredPrevious technical and managerial experience in conducting clinical pharmaceutical research studies in a hospital setting, a pharmaceutical company, or CROPrevious CRA experience preferredExperience or education indicating knowledge of medical and pharmaceutical terminology preferredPrevious experience in a Clinical Project Manager or Clinical Trial Manager level position preferredBenefitsTuition reimbursementGenerous health benefitsVacation packagesHybrid work from home opportunitiesPaid parental leaveCompany OverviewCTI is a full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services. It was founded in 1999, and is headquartered in Covington, Kentucky, USA, with a workforce of 1001-5000 employees. Its website is http://ctifacts.com.