Project Manager II, Real World Evidence – Late Phase Research

This is a fully remote position, open to applicants in Kentucky, +1 more state.

📋 Description

• Oversee and manage clinical studies related to Real World Evidence and other clinical projects.

• Represent and manage assigned functional team members involved in studies.

• Lead multi-functional study teams from the initiation phase through to project close-out.

• Ensure timely delivery, budget adherence, and high-quality standards from functional team members.

• Identify potential issues and escalate them to leadership while assisting with study resource allocation.

• Coordinate transitions of study team members as necessary.

• Initiate study start-up processes and kick-off meetings with clients and teams.

• Organize and facilitate both study kick-off and ongoing meetings with clients.

• Create timelines, trackers, project management plans, and other essential functional documentation.

• Monitor, recognize, and escalate study issues and risks; collaborate with the study team and clients to devise solutions.

• Prepare or supervise the creation of deliverables for clients and senior management.

• Provide project status updates to clients and management personnel.

• Manage project timelines and budgets, including budget reviews, revenue recognition, milestone payment approvals, and notifications for out-of-scope items.

• Ensure training and effective use of CTMS, eTMF, data systems, Smart Sheet, and other relevant systems.

• Collaborate with various multidisciplinary departments.

• Develop operating procedures tailored to specific projects as required.

• Assist in delivering presentations at client and Investigator Meetings, including bid defense sessions.

• Oversee day-to-day CRA tasks when a lead CRA is not assigned.

• Supervise RWE projects such as 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 modeling, advisory boards, surveys, feasibility assessments, and medical writing activities.

⛳️ Requirements

• A Bachelor's Degree or higher in a health science field, epidemiology, public health, pharmaceutical or medical device research, or a related health science discipline.

• A minimum of 5 years of experience in real world evidence, clinical, or business roles within drug or device research/development, biotechnology, pharmaceutical, or clinical research, or a combination of education and experience.

• Familiarity with real world evidence, the drug development process, and/or medical writing is preferred.

• Prior experience in overseeing monitoring activities is preferred.

• Proven experience in managing multi-functional study teams.

• Proficient in managing study timelines, budgets, risks, deliverables, and communications with clients.

• Competency in using CTMS, eTMF, data systems, Smart Sheet, and other client-specified systems.

• Experience in formulating project-specific operating procedures.

• Expertise in developing and delivering presentations for client and Investigator Meetings, 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 initiatives.

• Award-winning culture.

• Global team environment spanning 60 countries.