Proven Recruiting
Our clientis seeking an experienced and driven Associate Director, Clinical Operations to lead the planning, execution, and oversight of clinical trials from start-up through close-out. This role is critical in ensuring that trials are conducted efficiently, on time, and in compliance with regulatory standards and internal procedures. What you’ll do:
- Lead cross-functional study teams to manage all phases of clinical trials, ensuring timelines, budgets, and quality standards are met.
- Oversee CROs, vendors, and clinical sites to ensure accurate and compliant study execution.
- Develop and manage essential study documents, including protocols, informed consent forms, and monitoring plans.
- Facilitate vendor selection and contract negotiations for outsourced clinical activities.
- Provide regular study updates to senior leadership and contribute to strategic planning and process improvement.
- Bachelor’s degree in life science or related field with 8+ years of clinical research experience, including 5+ years in direct study management.
- Strong knowledge of ICH/GCP guidelines and regulatory requirements.
- Proven experience managing Phase 1–3 trials, including first-in-human and pre-NDA studies for inflammatory diseases.
- Proficiency with clinical systems such as eTMF, CTMS, and EDC platforms.
- Excellent communication, leadership, and organizational skills with the ability to work independently and cross-functionally.
- Compensation is determined by several factors which may include skillset, experience level, and geographic location. The expected salary range for this role is $180k – $200k per year. Please note this range is an estimate and actual pay may vary based on qualifications and experience.