Associate Director, Field Monitoring Operations
ImmunityBio, Inc.
August 25, 2026
Remote
United States
Clinical Research and Development
Position Summary:
The Associate Director, Field Monitoring Operations is responsible for designing, implementing, and overseeing the monitoring strategy (including RBQM and DCT components) to safeguard data integrity, patient safety, and regulatory compliance across the clinical trial portfolio. Leads a cross-functional team of remote Clinical Research Associates and Managers and partners with CROs and site investigators to create actionable monitoring plans.
Responsibilities:
- Lead clinical trials per protocols, SOPs, ICH GCP, and applicable regulatory requirements; mentor direct reports.
- Design, implement, and oversee RBQM frameworks and data surveillance aligned with ICH E6(R3).
- Integrate remote/on-site/decentralized monitoring with start-up, site activation, and close-out.
- Use negotiation, facilitation, meeting management, and conflict resolution to strengthen cross-functional operations.
- Optimize resource management strategy with cross-functional teams; ensure appropriate resourcing.
- Identify process issues and drive best-practice adoption and continuous improvement of processes, tools, reports, and systems.
- Provide quality oversight to support inspection readiness.
- Own/maintain Clinical Operations SOPs, including integrating modern risk-management frameworks.
- Support training, mentoring, and review of study-specific documents.
- Share cross-team/site learnings; perform ad-hoc projects as assigned.
Education & Experience (Required):
- Bachelor’s degree in life sciences/nursing/pharmacy/health-related (Master’s preferred) with 10+ years industry experience OR Master’s degree with 8+ years industry experience.
- 6+ years management experience in clinical trial operations.
Preferred:
- Experience in dynamic, fast-paced environments.
Skills/Abilities (Required):
- Leadership and collaboration; strong clinical research and ICH E6(R3) knowledge.
- Proven RBQM strategy expertise.
- Strong English communication; organizational/interpersonal skills; maintain confidentiality.
- Proficiency with MS Office and Veeva Clinical Vault, CTMS, eTMF.
Working Environment:
- Remote; Monday–Friday schedule with flexibility; travel up to 75%; flexible hours across time zones.
Benefits:
- Eligible for discretionary bonus and equity award.
- Medical, Dental and Vision Plan Options; EAP; Life/AD&D; Short-Term and Long-Term Disability; Flexible Spending Accounts; 401(k) match; 529 Education Savings; PTO and holidays; Unlimited PTO (exempt) or vacation/health pay/personal/cultural days (non-exempt).
Application Instructions:
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
The Associate Director, Field Monitoring Operations is responsible for designing, implementing, and overseeing the monitoring strategy (including RBQM and DCT components) to safeguard data integrity, patient safety, and regulatory compliance across the clinical trial portfolio. Leads a cross-functional team of remote Clinical Research Associates and Managers and partners with CROs and site investigators to create actionable monitoring plans.
Responsibilities:
- Lead clinical trials per protocols, SOPs, ICH GCP, and applicable regulatory requirements; mentor direct reports.
- Design, implement, and oversee RBQM frameworks and data surveillance aligned with ICH E6(R3).
- Integrate remote/on-site/decentralized monitoring with start-up, site activation, and close-out.
- Use negotiation, facilitation, meeting management, and conflict resolution to strengthen cross-functional operations.
- Optimize resource management strategy with cross-functional teams; ensure appropriate resourcing.
- Identify process issues and drive best-practice adoption and continuous improvement of processes, tools, reports, and systems.
- Provide quality oversight to support inspection readiness.
- Own/maintain Clinical Operations SOPs, including integrating modern risk-management frameworks.
- Support training, mentoring, and review of study-specific documents.
- Share cross-team/site learnings; perform ad-hoc projects as assigned.
Education & Experience (Required):
- Bachelor’s degree in life sciences/nursing/pharmacy/health-related (Master’s preferred) with 10+ years industry experience OR Master’s degree with 8+ years industry experience.
- 6+ years management experience in clinical trial operations.
Preferred:
- Experience in dynamic, fast-paced environments.
Skills/Abilities (Required):
- Leadership and collaboration; strong clinical research and ICH E6(R3) knowledge.
- Proven RBQM strategy expertise.
- Strong English communication; organizational/interpersonal skills; maintain confidentiality.
- Proficiency with MS Office and Veeva Clinical Vault, CTMS, eTMF.
Working Environment:
- Remote; Monday–Friday schedule with flexibility; travel up to 75%; flexible hours across time zones.
Benefits:
- Eligible for discretionary bonus and equity award.
- Medical, Dental and Vision Plan Options; EAP; Life/AD&D; Short-Term and Long-Term Disability; Flexible Spending Accounts; 401(k) match; 529 Education Savings; PTO and holidays; Unlimited PTO (exempt) or vacation/health pay/personal/cultural days (non-exempt).
Application Instructions:
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).