CTI Clinical Trial and Consulting Services · 2 hours ago
Project Manager II/Sr., Real World Evidence/ Late Phase Research
Covington, KY
Full-time
Hybrid
Senior Level
5+ years expCTI Clinical Trial and Consulting Services is a global clinical contract research organization focused on advancing treatments for critically ill patient populations. The Project Manager II/Sr. will oversee and coordinate all operational aspects of Real World Evidence clinical studies, ensuring quality, timeliness, and client satisfaction from planning to completion.
BiotechnologyConsultingPharmaceutical
Responsibilities
Oversee and manage RWE clinical studies and other clinical projects. RWE clinical studies include, but are not limited to: Disease or drug registries, Natural History of Disease studies, Post-marketing required studies, Decentralized trials, Pragmatic trials, Long term follow-up studies, Retrospective studies, Early Access Programs (EAP’s), Other clinical programs primarily observational or low-interventional in design
Other areas of oversight and coordination could include, but are not limited to the following project types, in conjunction with research scientists: Systematic Literature Reviews and Meta Analyses, Database analyses, Development of Economic models, Oversight of advisory boards, surveys and feasibility assessments, Additional medical writing activities (protocols, clinical study reports, abstracts, manuscripts, posters and white papers)
Manage multi-functional study teams throughout the study or project from kick-off through close-out. Responsible for ensuring all functional areas study team members deliver in a timely manner, on budget and with high quality throughout the duration of the study. Responsible for escalation of potential issues to leadership, as necessary
Assist in study resourcing needs with other functional areas, when needed. Ensure proper transition with any new study team members throughout the study
Work closely with the client and team to initiate study start-up and kick off. Organize and lead study kick-off meetings and ongoing client meetings throughout the duration of the study or project
Develop timelines, trackers, project management plans and provide oversight for other key functional plans to ensure they are developed, reviewed and approved by the client, based on study scope
Monitor for potential issues and risks throughout the study, quickly identify and escalate to leadership as needed, brainstorm solutions to present to the study team and client
Prepare or oversee development, review, and finalization of deliverables for clients and senior management. Provide project status reports to client and management
Manage timelines and budgets, collaborating with finance and leadership to ensure project remains on time and in budget. Conduct regular reviews of the budget and scope, including revenue recognition and approval of milestone payments. When needed, initiate out of scope notifications to clients
Ensure training and utilization of various systems to support RWE programs, including but not limited to CTMS, eTMF, data systems, Smart Sheet and any others requested by clients
Interact with multidisciplinary departments
Develop project-specific operating procedures (PSOPs), as necessary, with responsible functional areas
Assist in the development and leadership of presentations at client and Investigator Meetings, including bid defense meetings
Provide day-to-day oversight of CRA tasks on assigned projects when a lead CRA is not assigned
Qualification
Required
Bachelor's Degree or above in a health science field, epidemiology, public health, pharmaceutical or medical device research, or related health science field
5 years real world evidence, clinical or business background in drug or device research/development, biotechnology, pharmaceutical or clinical research and/or combination of education & experience
Preferred
Experience with real world evidence, drug development process and/or medical writing
Experience in the oversight of Monitoring activities
Benefits
Tuition reimbursement
Generous health benefits
Vacation packages
Hybrid work from home opportunities
Paid parental leave
Company
CTI Clinical Trial and Consulting Services
CTI is a full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Timothy Schroeder
Chairman & CEO | Founder
Recent News
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