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

CTI Clinical Trial and Consulting Services • Raleigh, NC

19d

About The Position

CTI Clinical Trial and Consulting Services is seeking a Project Manager II/Senior to oversee and coordinate the operational aspects of Real World Evidence (RWE) clinical studies and projects according to contract. The role ensures quality, timeliness, and client satisfaction from planning through completion, and manages and represents assigned functional study team members.

The position oversees RWE studies such as disease or drug registries, natural history studies, post-marketing required studies, decentralized and pragmatic trials, long-term follow-up studies, retrospective studies, Early Access Programs, and other primarily observational or low-interventional clinical programs. It may also coordinate projects such as systematic literature reviews and meta-analyses, database analyses, economic models, advisory boards, surveys, feasibility assessments, and medical writing activities.

The Project Manager leads multidisciplinary teams, works closely with clients, manages study start-up and meetings, oversees plans and deliverables, monitors risks, and manages project timelines and budgets. The role also supports resourcing and team transitions, ensures appropriate 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 no lead CRA is 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.
• Five 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, including observational and low-interventional programs.
• Coordinate additional project types such as literature reviews, meta-analyses, database analyses, economic models, advisory boards, surveys, feasibility assessments, and medical writing activities.
• Manage multifunctional study teams from kick-off through close-out, ensuring timely, on-budget, high-quality delivery and escalating potential issues to leadership.
• Assist with study resourcing and ensure effective transitions when new study team members join.
• Work with clients and teams to initiate study start-up, organize and lead kick-off meetings, and conduct ongoing client meetings.
• Develop timelines, trackers, and project management plans, and oversee the development, review, and client approval of other functional plans based on study scope.
• Monitor risks and potential issues, escalate them as needed, and develop solutions with the study team and client.
• Prepare or oversee the development, review, and finalization of client and senior-management deliverables, and provide project status reports.
• Manage project timelines and budgets in collaboration with finance and leadership; review budgets and scope, revenue recognition, and milestone payment approvals, and initiate out-of-scope notifications when needed.
• Ensure training and use of systems supporting RWE programs, including CTMS, eTMF, data systems, Smart Sheet, and systems requested by clients.
• Interact with multidisciplinary departments.
• Develop project-specific operating procedures with responsible functional areas as needed.
• Assist in 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.

Benefits

• Tuition reimbursement.
• Health benefits.
• Vacation packages.
• Hybrid work opportunities.
• Paid parental leave.
• Professional growth opportunities, including mentoring, leadership development courses, education, and training.

What This Job Offers

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