Project Manager II/Sr., Real World Evidence/ Late Phase Research

Join The CTI Team • Covington, KY

18d • Hybrid

About The Position

Responsible for overseeing and coordinating all operational aspects of Real World Evidence (RWE) clinical studies and projects according to contract ensuring quality, timeliness, and client satisfaction from planning to completion. Manage and represent assigned functional study team members in RWE studies and projects. 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.

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

Nice To Haves

• Experience with real world evidence, drug development process and/or medical writing preferred
• Experience in the oversight of Monitoring activities preferred

Responsibilities

• Oversee and manage RWE clinical studies and other clinical projects.
• 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.

Benefits

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

What This Job Offers

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