Senior Clinical Trial Operations Lead

ADARx Pharmaceuticals, Inc.; San Diego (CA); On-site; USD 150,000 - 165,000; Full time

Job summary

ADARx Pharmaceuticals, Inc. is seeking a (Sr.) Clinical Trial Manager to lead and coordinate one or more trials in Clinical Operations. You will manage vendors, oversee trial execution and ensure compliance with ICH-GCP, SOPs and regulatory requirements.

The role requires 8+ years (Sr. 10+) in Phase 1-3 trials, global time-zone experience, and strong communication skills. Located in San Diego; occasional travel may be required. Competitive salary and full benefits are offered.

Qualifications

• BA/BS in life and health sciences (biology, pharmacology, pharmaceutical sciences or equivalent).
• 8+ years managing Phase 1-3 trials; Sr. level 10+ years preferred.
• Global time zones experience including EU/APAC.
• Experience in site monitoring visits (remote preferred).
• Experience in CRO/vendor management.
• ICH/GCP/IRB/IEC regulatory knowledge.
• Proficient with MS Office, EDC, RTSM, CTMS, eTMF.
• Ability to travel domestically and internationally.
• Understand project timelines and deliverables.
• Global biotech/pharma experience preferred.
• Small to mid-size biotech/pharmaceutical experience preferred.

Responsibilities

• Plan and conduct clinical trials per protocol, SOPs and regulatory standards.
• Manage vendors and CROs to meet time and budget goals.
• Ensure study conduct aligns with ICH-GCP and QA requirements.
• Generate metrics and reports for study progress and site performance.
• Oversee TMF filing, trial documentation and data quality.
• Collaborate with Medical, Data Management, Regulatory and Legal teams.

Skills

Independent work

Communication skills

Problem solving

Adaptability

Cross-functional collaboration

Education

BA/BS in life and health sciences

Tools

Microsoft Office

EDC

RTSM

CTMS

eTMF

Job description

ADARx Pharmaceuticals, Inc. is seeking a (Sr.) Clinical Trial Manager to lead and coordinate one or more trials in Clinical Operations. You will manage vendors, oversee trial execution and ensure compliance with ICH-GCP, SOPs and regulatory requirements.

The role requires 8+ years (Sr. 10+) in Phase 1-3 trials, global time-zone experience, and strong communication skills. Located in San Diego; occasional travel may be required. Competitive salary and full benefits are offered.