IXRS/eCOA Validation Lead
Remote from anywhere in the U.S. or Canada
- Proactively follow-up with customers and third-party vendors to ensure comprehensive understanding of requirements and design in order to provide quality deliverables.
- Active participation in study team meetings.
- Review and provide input on requirements and specifications.
- Create validation documentation – UAT Test Plan, test scripts, and defect tracker.
- Direct teams during testing execution for initial implementation and updates. Function as point of contact during UAT for team members, triaging and resolving issues as needed.
- Manage UAT plans and timelines, ensuring that team members adhere to the schedules and timetables for the completion of projects.
- Advise the team and stakeholders, informing on the processes that will be completed to enable system implementation.
- Degree in a mathematical, computing, life sciences, or related discipline
- Minimum 2-4+ years of experience in clinical systems such as CTMS, ePRO, IXRS, EDC or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Strong oral and written communication skills. Experienced project leader and presenter.
- Proficiency in converting complex technical and business requirements into clear test plan and test cases.
- Understanding of Drug Development and Clinical Trial Processes
- Understanding of Data Management Processes
- In-depth knowledge of Good Clinical Practices
- Understanding of Clinical Research System Development Lifecycle
- Must have sound problem resolution, judgment and decision-making skills.
- Ability to prioritize tasks effectively and manage multiple projects simultaneously.