- Serves as the Quality Lead for assigned clinical programs providing GCP compliance interpretation, consultation, and other supportive services necessary to maintain and/or improve the quality of Vertex research to ensure the protection of subjects' safety, rights, and well-being as well as the integrity and credibility of data generated.
- Maintains a contemporary knowledge of current industry trends, standards, and methodologies as it relates to Good Clinical Practice (GCP).
- Liaise with Vertex clinical functions and external parties including CROs, Vendors and investigator sites to promote high level of quality and consistency across and within programs.
- Provides QA review of protocols and participates on Operational Review Boards to identify operational risks and collaborates with study team in development of risk mitigation strategies.
- M.S. (or equivalent degree) and 7+ years of relevant work experience, or B.S. and 10+ years of relevant GCP work experience
- Maintain contemporary knowledge and awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development (e.g., FDA regulations, EU Regulations and Directives, MHRA Statutory Instruments, etc.)
- Experience with all phases of clinical trial development involving drugs, biologics, devices and drug/ device combinations.
- Device experience preferred but not required
- Working knowledge of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks.
- Ability to understand and translate customer needs for innovation and creative approaches to quality management
- Communicates professionally, clearly, concisely, and consistently both verbally and in writing to internal and external customers.
- Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.
- Demonstrates proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
- Proficient in using Microsoft Office applications is an asset (MS Word, MS Excel, MS PowerPoint, Visio).