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 support one or more trials in Clinical Operations from San Diego, CA.

This full-time role oversees planning, execution, and vendor management to ensure milestones are met and regulatory standards are upheld. You will collaborate with cross-functional teams across global sites, manage trial documentation, and support safety reviews and data integrity while driving timelines and budgets in a dynamic biotech

Qualifications

• BA/BS in life and health sciences or equivalent experience.
• 8+ years of managing Phase 1-3 clinical trials; Sr. 10+ years preferred.
• Ability to work across global time zones (EU, APAC).
• Experience in CRO/vendor management (domestic/international).
• Knowledge of ICH, GCP, IRB/IEC requirements.

Responsibilities

• Lead clinical operations activities for one or more trials per SOPs and regulatory requirements.
• Manage vendors and CROs to ensure on-time, on-budget study execution.
• Monitor trial activities with study team and vendors, ensuring inspection readiness and regulatory compliance.
• Generate metrics and reports (CTMS, DM queries, monitoring reports) for study governance.
• Maintain TMF filing and QA processes; oversee site activation and patient enrollment.
• Support safety reporting and data review; provide trial plans and study documents.
• Collaborate with internal groups (Medical, Regulatory, QA, Finance, Legal) to achieve goals.

Skills

Global time zones

CRO/Vendor management

Cross-functional collaboration

Strong communication skills

Education

BA/BS in life and health sciences

Tools

MS Office Suite

EDC

RTSM

CTMS

eTMF

Job description

ADARx Pharmaceuticals Inc. is seeking a (Sr.) Clinical Trial Manager to lead and support one or more trials in Clinical Operations from San Diego, CA.

This full-time role oversees planning, execution, and vendor management to ensure milestones are met and regulatory standards are upheld. You will collaborate with cross-functional teams across global sites, manage trial documentation, and support safety reviews and data integrity while driving timelines and budgets in a dynamic biotech