Project Manager II/Senior, Real World Evidence/ Late Phase Research

Join The CTI Team • Covington, KY

13d

About The Position

The Project Manager II/Senior oversees and coordinates operational aspects of Real World Evidence (RWE) clinical studies and related projects according to contract, ensuring quality, timeliness, and client satisfaction from planning through completion. The role manages and represents assigned functional study team members and leads multidisciplinary teams from project kick-off through close-out.

Projects may include disease or drug registries, natural history studies, post-marketing studies, decentralized or pragmatic trials, long-term follow-up and retrospective studies, Early Access Programs, and other primarily observational or low-interventional clinical programs. Additional work may include systematic literature reviews and meta-analyses, database analyses, economic models, advisory boards, surveys, feasibility assessments, and medical writing deliverables.

The project manager works closely with clients and internal teams to initiate projects, coordinate meetings, establish and monitor plans and timelines, manage budgets and scope, oversee deliverables and reporting, identify and escalate risks, and support study resourcing and team transitions. The role also ensures appropriate training and use of project systems, develops project-specific operating procedures as needed, contributes to client and investigator presentations, and provides day-to-day oversight of CRA tasks when a lead CRA is not assigned.

Requirements

• Bachelor’s degree or above in a health science field, epidemiology, public health, pharmaceutical or medical device research, or a related health science field.
• At least 5 years of real world evidence, clinical, or business background in drug or device research/development, biotechnology, pharmaceutical or clinical research, or a combination of education and experience.

Nice To Haves

• Experience with real world evidence, the drug development process, and/or medical writing.
• Experience overseeing monitoring activities.

Responsibilities

• Oversee and manage RWE clinical studies and other clinical projects.
• Manage multidisciplinary study teams from kick-off through close-out and ensure functional team members deliver on time, within budget, and with high quality.
• Escalate potential issues to leadership and assist with study resourcing and transitions for new team members.
• Work with clients and study teams to initiate projects and lead kick-off and ongoing client meetings.
• Develop timelines, trackers, and project management plans, and oversee other key functional plans according to study scope.
• Monitor project risks and issues, identify and escalate concerns, and develop potential solutions with the team and client.
• Prepare or oversee the development, review, and finalization of client and senior management deliverables.
• Provide project status reports to clients and management.
• Manage timelines and budgets in collaboration with finance and leadership; review budget and scope, revenue recognition, and milestone payment approvals.
• Initiate out-of-scope notifications to clients when needed.
• Ensure training and use of systems supporting RWE programs, including CTMS, eTMF, data systems, Smart Sheet, and client-requested systems.
• Interact with multidisciplinary departments.
• Develop project-specific operating procedures with responsible functional areas as needed.
• Assist with developing and leading 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.
• Coordinate additional project work that may include literature reviews and meta-analyses, database analyses, economic models, advisory boards, surveys, feasibility assessments, and medical writing.

Benefits

• Professional growth through a structured mentoring program, leadership development courses, and ongoing education and training.
• Tuition reimbursement.
• Health benefits.
• Vacation packages.
• Hybrid work opportunities.
• Paid parental leave.
• Opportunities to give back through the CTI Cares program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level