Process Training Execution Lead

Job Summary

To ensure the quality and compliance of clinical trials, the full-time remote Process Training Execution Lead will manage the implementation strategy for the Development organization, collaborating with various teams to optimize processes and maintain controlled documents.

Key responsibilities:

• Drive the development, optimization, implementation, and maintenance of Development processes and controlled documents
• Draft, revise, and maintain controlled documents, ensuring they meet applicable standards and are ready for review and implementation
• Facilitate cross-functional working sessions to gather requirements and drive process changes to completion

Required qualifications:

• BA/BS required; advanced degree preferred with applicable experience considered in lieu of education
• Minimum of 10+ years of experience in a clinical research environment within the pharmaceutical and biotech industry
• Demonstrated experience drafting and managing GxP controlled documents, including SOPs and work instructions
• Experience with Veeva QualityDocs or similar electronic document management systems
• Strong understanding of appropriate regulations and guidelines (e.g., FDA and ICH GCP guidelines) applicable to clinical trials