Bachelor's Degree in health science, epidemiology, public health, or related field
5 years of experience in real world evidence or clinical research
Background in drug or device research/development
Familiarity with the drug development process
Experience in medical writing is a plus
Responsibilities
Oversee and manage RWE clinical studies and projects from planning to completion
Coordinate with research scientists on systematic literature reviews and database analyses
Manage multi-functional study teams to ensure timely and quality deliverables
Assist in resource allocation and onboarding of new team members
Lead study kick-off meetings and maintain ongoing client communication
Develop and monitor project timelines, trackers, and management plans
Identify and escalate potential issues and risks to leadership
Benefits
Opportunity to work on diverse RWE clinical studies
Collaborative environment with multidisciplinary teams
Engagement in high-impact projects with client interaction
Professional development opportunities in clinical research
Access to advanced project management tools and systems
Full Job Description
Job Purpose/ Summary: 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.
What You'll Do:
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.
What You'll Bring:
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
