Senior Clinical Trials Lead - Strategy & Execution

Bayside Solutions; Fremont (CA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Bayside Solutions in Redwood City, CA, is seeking a motivated Clinical Operations professional to oversee end-to-end study execution in compliance with FDA and ICH guidelines. The role involves coordinating cross-functional teams, vendors, and study milestones to meet objectives and budgets.

You’ll develop study plans, track timelines and metrics, report to senior management, identify risks, and ensure data quality from start-up through close-out, with domestic/international travel up to 25%.

Qualifications

• 3-5 years of experience in clinical and drug development.
• BS/BA in Life Sciences or related discipline.
• Strong knowledge of FDA & ICH/GCP regulations.

Responsibilities

• Manage the execution of clinical studies, with milestones, timelines and vendor selection.
• Prepare timely study updates and reports for senior management.
• Identify risks and implement mitigation strategies.
• Oversee start-up, treatment, maintenance and close-out stages.
• Ensure data quality and regulatory compliance (FDA/ICH/GCP).

Skills

Team collaboration

Written & verbal communication

Strategic thinking

Time management

Cross-functional collaboration

Education

BS/BA in Life Sciences

Tools

MS Office

Job description

Bayside Solutions in Redwood City, CA, is seeking a motivated Clinical Operations professional to oversee end-to-end study execution in compliance with FDA and ICH guidelines. The role involves coordinating cross-functional teams, vendors, and study milestones to meet objectives and budgets.

You’ll develop study plans, track timelines and metrics, report to senior management, identify risks, and ensure data quality from start-up through close-out, with domestic/international travel up to 25%.