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 initiation activities in alignment with client protocols, documentation, ICH-GCP, and applicable regulations.

• Prepare, assess, monitor, and manage regulatory documentation for sites at both the country and site levels.

• Maintain, evaluate, and report on metrics related to site performance.

• Collaborate with Clinical Research Associates (CRAs) and the Local Study Team/Local Study Associate Director to fulfill study initiation tasks and objectives.

• Assist in the clinical and operational feasibility evaluations of prospective studies.

• Manage the gathering, preparation, assessment, and tracking of documentation for application processes.

• Submit applications and documentation to Regulatory Authorities and/or Institutional Ethics Committees (IEC)/Institutional Review Boards (IRB) during the initiation phase.

• Engage in Local Study Team meetings.

• Update the Clinical Trial Management System (CTMS) and other platforms with study site information within specified timeframes.

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

• Collect and upload critical documents into the electronic Trial Master File (eTMF) and assist with quality control checks.

• Provide Line Managers with consistent updates on study milestones and significant issues.

⛳️ Requirements

• Bachelor’s Degree, preferably in a life sciences discipline.

• At least 5 years of experience in a Clinical Research setting, specifically in Start-Up activities.

• Strong project management competencies, with a thorough understanding of regulatory and submission protocols.

• Exceptional written and verbal communication skills.

• Demonstrated ability to work effectively under tight deadlines and manage various 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 clear career pathways.