US Study Start Up Lead

About the role

For our client, we are seeking a US Study Start Up Lead to join the team of a leader in the Pharmaceuticals & Biotech space. This role will drive the timely startup of clinical studies across therapeutic areas, with a strong focus on country-specific readiness, site activation, and regulatory coordination. You will partner closely with study teams, operational stakeholders, and external partners to keep start-up activities on track from initial site engagement through initiation. The position also calls for strong forecasting, process improvement, and the use of AI-enabled tools to improve efficiency in clinical trial operations. Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Ensure timely start-up of clinical studies across therapeutic areas
• Support collaboration between study teams for start-up activities
• Accurately forecast critical study timelines for country-specific start-up activities
• Maintain tracking of study site status from initial contact to initiation
• Deliver country feasibility, site selection, and regulatory package completion
• Coordinate documentation for study start-up, including ethics submissions
• Identify and share best practices for process optimization
• Stay updated on changes in site start-up requirements
• Utilize AI tools to enhance efficiency in clinical trial operations

Qualifications

• Bachelor's degree in Sciences or equivalent experience
• 3+ years of experience in clinical operations or related positions
• Familiarity with ICH-GCP and local regulatory processes
• Leadership experience in matrix teams preferred
• Strong analytical skills and a results-driven mindset preferred

Benefits

• Health care insurance for employees and families
• Retirement benefits
• Paid holidays and vacation
• Paid caregiver, parental, and medical leave
• Annual bonus and share-based long-term incentive program

Pay

$115,500 – $192,500 annually