CRO-Project Manager
Evolution Research Group
Job Level
Mid-LevelSenior
About the role
- Support all COAs (Clinician Reported Outcomes, Patient Reported Outcomes, Observer Reported Outcomes, & Performance Outcomes)
- Assist in the implementation of eCOA and paper-based COA during clinical trial execution
- Act as a core team member for eCOA development, including device testing, deployment, and ongoing maintenance
- Provide expertise on PRO/COA scientific principles to ensure consistency across Therapeutic Areas and seamless integration among eCOA vendors
- Ensure the ongoing quality, precision, and integrity of COA instruments throughout clinical trials
- Contribute to vendor selection processes and provide input
- Participate in specification meetings to support the design of ePRO application and monitoring reports
- Review and approve ePRO specifications, screens, and prototypes and escalate concerns when necessary
- Develop and execute the PRO Completion Guidelines
- Serve as a key member of User Acceptance Testing, execute assigned cases, document issues, and collaborate with cross-functional partners for resolution
- Share best practices and lessons learned across studies, Therapeutic Areas, and teams
- Contribute to documentation that enhances COA processes, such as training materials and responsibility matrices
- Monitor compliance metrics that impact PRO/COA quality
- Stay informed on the latest scientific and industry best practices related to PRO/COA
Requirements
- An undergraduate degree from an accredited institution or international equivalent required
- Read, write and speak English
- Four plus years of experience in CRO or healthcare related industry
- Proficient in Microsoft Office
- Working knowledge of Patient Focused Drug Development (PFDD) and 2009 PRO FDA Guidance and other relevant guidance and best practices is preferred
- Strong interpersonal skills and demonstrated ability to work effectively as a member of cross-functional teams
- Expertise working with eCOA/COA/ePRO
- Strong analytical skills with a keen eye for detail
- Excellent listening, verbal, and written communication skills
- Ability to work independently and to involve management when needed
