Project Manager II/Sr., Real World Evidence/Late Phase Research
Posted 1 week ago
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Oversee and coordinate all operational aspects of Real World Evidence (RWE) clinical studies and projects, ensuring quality, timeliness, and client satisfaction from planning to completion. Manage and represent assigned functional study team members in RWE studies and projects.
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
- Work closely with the client and team to initiate study start-up and kick off
- Develop timelines, trackers, project management plans and provide oversight for other key functional plans
- Monitor for potential issues and risks throughout the study, quickly identify and escalate to leadership as needed
- Prepare or oversee development, review, and finalization of deliverables for clients and senior management
- Manage timelines and budgets, collaborating with finance and leadership to ensure project remains on time and in budget
- Ensure training and utilization of various systems to support RWE programs
- Interact with multidisciplinary departments
- Develop project-specific operating procedures (PSOPs), as necessary, with responsible functional areas
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
Qualifications
- 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 Have
- Experience with real world evidence, drug development process and/or medical writing
- Experience in the oversight of Monitoring activities
Skills
* Required skills
Benefits
About CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, fro...