Support planning, execution, and closeout of trials
Ensure trial activities are conducted in accordance with protocols, SOPs, and GCP
Assigned clinical trials are executed according to plan, timeline, and quality expectations
Study documentation and systems remain accurate and up to date
Identify and escalate potential impacts to timeline, cost, or quality
Support development of mitigation plans in partnership with study leadership
Communicate effectively with Clinical Operations, Data Management, Regulatory, CMC, and external partners
Support alignment across stakeholders on study priorities and expectations
Assist with vendor and site budgets, supporting invoice and budget activities
Assist with site management activities, including review of monitoring reports and tracking site visits
Maintain Trial Master File completeness and accuracy
Support compliance activities, quality issue identification, and resolution
Ensure timely updates to CTMS, clinical trial registries, and internal systems
Communicate study status, metrics, and emerging issues with clarity and urgency
Maintain trial inspection-readiness
Support development of study tools, templates, and training materials
Contribute to process improvements, SOPs, and departmental initiatives

BA/BS degree in life sciences or related discipline
8+ years of experience in biotech or pharmaceutical clinical drug development
Hands‑on experience supporting Phase 1–3 clinical trials
Working knowledge of GCP, clinical trial systems, and regulatory requirements
Experience working with CROs, vendors, and investigative sites
Strong organizational skills with the ability to manage multiple priorities
Proficiency with Microsoft Office and clinical data systems (e.g., CTMS, eTMF)
Experience in rare disease, specialty indications, and/or gene or cell therapy preferred

Associate Director, Clinical Trials

Key skills