Project Manager II, Real World Evidence – Late Phase Research

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🐎 Kentucky, North Carolina – Remote

🐎 Kentucky – Remote 🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Oversee and manage Real World Evidence clinical studies and other clinical projects • Manage and represent assigned functional study team members • Manage multi-functional study teams from kick-off through close-out • Ensure functional team members deliver on time, within budget, and to high quality standards • Escalate potential issues to leadership and assist with study resourcing • Coordinate study team member transitions • Initiate study start-up and kick-off with clients and teams • Organize and lead study kick-off and ongoing client meetings • Develop timelines, trackers, project management plans, and other functional plans • Monitor, identify, and escalate study issues and risks; develop solutions with the study team and client • Prepare or oversee client and senior-management deliverables • Provide project status reports to clients and management • Manage timelines and budgets, including budget and scope reviews, revenue recognition, milestone payment approvals, and out-of-scope notifications • Ensure training and utilization of CTMS, eTMF, data systems, Smart Sheet, and other systems • Interact with multidisciplinary departments • Develop project-specific operating procedures as needed • Assist with presentations at client and Investigator Meetings, including bid defense meetings • Provide day-to-day oversight of CRA tasks when no lead CRA is assigned • Oversee RWE projects including registries, natural history studies, post-marketing studies, decentralized and pragmatic trials, long-term follow-up, retrospective studies, Early Access Programs, literature reviews, meta-analyses, database analyses, economic models, advisory boards, surveys, feasibility assessments, and medical writing activities

🎯 Requirements

• 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 • Experience with real world evidence, drug development process and/or medical writing preferred • Experience in the oversight of Monitoring activities preferred • Experience managing multi-functional study teams • Ability to manage study timelines, budgets, risks, deliverables, and client communications • Ability to use CTMS, eTMF, data systems, Smart Sheet and other client-requested systems • Experience developing project-specific operating procedures • Experience developing and leading client and Investigator Meeting presentations, including bid defense meetings • Equal Opportunity Employer/Veterans/Disabled

🏖️ Benefits

• Structured mentoring program • Leadership development courses • Ongoing education and training opportunities • Tuition reimbursement • Generous health benefits • Vacation packages • Hybrid work opportunities • Paid parental leave • CTI Cares community-giving opportunities • Award-winning culture • Global team environment spanning 60 countries