Study Start-up Lead

This is a fully remote position, open to applicants in North Carolina, +1 more state.

📋 Description

• Oversee and execute country-specific study start-up activities in alignment with client protocols, ICH-GCP, and applicable regulations.

• Develop, evaluate, monitor, and manage regulatory documentation at both the country and site levels.

• Maintain, assess, and report on performance metrics for study sites.

• Collaborate with Clinical Research Associates (CRAs) and the Local Study Team/Local Study Associate Director to accomplish study start-up activities and meet milestones.

• Contribute to evaluations of clinical and operational feasibility.

• Manage the collection, preparation, evaluation, and tracking of documents for regulatory submissions.

• Submit applications and documentation to Regulatory Authorities and/or IEC/IRB during the start-up phase.

• Engage in Local Study Team meetings.

• Update Clinical Trial Management System (CTMS) and other databases with study-site information within specified deadlines.

• Follow up on pending actions with study sites to ensure prompt resolution.

• Gather and upload essential documents to the electronic Trial Master File (eTMF) and assist with quality-control checks.

• Provide country-specific updates to Line Managers regarding study milestones and critical issues.

⛳️ Requirements

• Bachelor's Degree, ideally in life sciences.

• At least 5 years of experience in a Clinical Research setting, with an emphasis on Start-Up.

• Strong project management capabilities, with in-depth knowledge of regulatory and submission processes.

• Exceptional written and verbal communication skills.

• Demonstrated ability to work effectively under tight deadlines and juggle multiple priorities.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.