Related skills
gcp ich guidelines sops tmf regulatory compliance📋 Description
- Lead TMF operations and act as SME across study teams, CROs, and vendors.
- Ensure TMF content is timely, complete, and of high quality for studies.
- Drive change management and promote enhanced TMF processes and standards.
- Oversee TMF vendors and coordinate with IT on eTMF platform configuration.
- Develop and implement TMF processes, SOPs, supporting tools, and training.
- Lead a TMF team, recruitment, training, and performance management.
🎯 Requirements
- Bachelor's degree or higher
- 10+ years leading TMF activities in clinical research
- Experience with Veeva Vault eTMF strongly preferred
- Experience with implementation and integration of eTMF platforms
- Experience with computer system validation and assurance
- Knowledge of TMF reference model regulations GCP and ICH guidelines
🎁 Benefits
- Culture rooted in CORE values Caring Original Resilient Egoless
- Fast paced environment with cross functional roles
- Competitive compensation base salary bonus equity benefits
- Generous PTO and company shutdowns plus paid sick leave
- Professional growth and development opportunities
- Regular all team in person meetings
Meet JobCopilot: Your Personal AI Job Hunter
Automatically Apply to Operations Jobs. Just set your
preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.
Help us maintain the quality of jobs posted on Empllo!
Is this position not a remote job?
Let us know!