Clinical Operations Lead — Cross-Functional Trials

vanguardclinical; California (MO); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Vanguard Clinical, Inc. in San Diego, CA, is seeking a Clinical Operations Specialist (COS) to drive key operational activities across Clinical Operations, SSU, TMF, Data Management, and Vendor Oversight.

This experienced professional will support site activation, study startup timelines, and cross-functional coordination. The COS will mentor Clinical Operations Associates, contribute to process improvements, and serve as a core operational contributor on assigned studies, with flexibility to

Qualifications

• Minimum 3 years of clinical research experience, preferably in CRO, sponsor, or academic settings.
• Proficiency with clinical systems such as eTMF, EDC, CTMS, IWRS, or study tracking tools.
• Strong understanding of ICH-GCP, GDP, and clinical research processes from start-up to close-out.
• Ability to independently manage multiple tasks and deadlines with minimal supervision.
• Flexible and adaptable to support diverse client needs with a customer-service mindset.

Responsibilities

• Lead cross-functional coordination across the clinical trial lifecycle.
• Manage study trackers, site updates, enrollment metrics, and operational reporting.
• Coordinate with CRAs, PMs, Data Management, SSU, Safety, and TMF teams.
• Support SSU activities: document QC, site activation readiness, and ICF customization.
• Support TMF management with QC, filing, and audit readiness.
• Mentor Clinical Operations Associates and support onboarding.
• Support onboarding for new team members and contribute to continuous improvement initiatives.

Skills

Clinical research experience

CRO/Sponsor oversight

eTMF/EDC/CTMS/IWRS familiarity

ICH-GCP/GDP knowledge

Cross-functional coordination

Tools

eTMF

EDC

CTMS

IWRS

Study tracking tools

Job description

Vanguard Clinical, Inc. in San Diego, CA, is seeking a Clinical Operations Specialist (COS) to drive key operational activities across Clinical Operations, SSU, TMF, Data Management, and Vendor Oversight.

This experienced professional will support site activation, study startup timelines, and cross-functional coordination. The COS will mentor Clinical Operations Associates, contribute to process improvements, and serve as a core operational contributor on assigned studies, with flexibility to