Associate Director, Clinical Operations Standards and Planning
Related skills
process improvement vendor management clinical operations 21 cfr part 11 ich-gcp📋 Description
- Identify operational efficiencies with CROs and vendors to support trial delivery.
- Lead Clinical Operations resource planning to ensure timely staffing.
- Develop and maintain standards for global clinical trials across programs.
- Collaborate with Process Excellence and QA to standardize study operations.
- Oversee resource planning to optimize utilization across the organization.
- Drive end-to-end clinical operations processes with cross-functional teams.
🎯 Requirements
- 12+ years pharma/biotech Clinical Ops experience.
- Bachelor's degree required.
- Experience overseeing CROs, vendors, and trial consultants.
- Experience operationalizing large global trials.
- Strong leadership, communication, and cross-functional influence.
- Deep knowledge of ICH-GCP, 21 CFR Part 11, and health authority regs.
🎁 Benefits
- Great culture based on C.O.R.E. values.
- Fast-paced environment with growth and learning.
- Market-competitive compensation and benefits package.
- Generous time off: 3 weeks PTO, two shutdown weeks.
- Commitment to professional development resources.
- Regular all-team in-person meetings to build relationships.
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