Global Study Start-Up & Site Activation Lead

CTI Clinical Trial and Consulting Services; Raleigh (NC); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work from home

Health benefits

Vacation package

Parental leave

Job summary

CTI Clinical Trial and Consulting Services seeks a senior professional to lead global study start-up and site activation for assigned trials from strategy through execution. You will coordinate across feasibility, regulatory, site contracts, and clinical operations to ensure timely activation and TMF readiness.

Ideal candidates bring 8+ years in clinical research, expertise in start-up dependencies and regulatory submissions, and a proven ability to manage multiple trials across countries within

Qualifications

• Bachelor’s degree in life sciences or related field.
• 8+ years of clinical research experience, including start-up and site activation.
• Experience leading global start-up initiatives across multiple trials and countries.

Responsibilities

• Develop and lead global study start-up and site activation strategy for assigned trials, including activation assumptions, country/site sequencing, critical path dependencies, milestones, and mitigation plans.
• Establish and maintain country/site activation plans aligned with sponsor expectations, timelines, scope, and team priorities.
• Serve as primary operational point for study-start-up status, risks, escalations, and recovery planning.
• Partner with Feasibility, Clinical Operations, Regulatory Affairs, and country teams to support activation planning, submissions, and site readiness.
• Monitor activation metrics, dashboards, and project tracking to assess milestone progress, data quality, and cycle-time risks.
• Ensure TMF completeness, inspection readiness, and compliance with ICH/GCP and sponsor requirements.
• Provide concise start-up updates and decisions in governance and sponsor meetings.

Skills

Study start-up leadership

Site activation strategy

Cross-functional collaboration

Regulatory submissions

CTI SOPs knowledge

Education

Bachelor’s degree in life sciences

Master’s degree preferred

Job description

CTI Clinical Trial and Consulting Services seeks a senior professional to lead global study start-up and site activation for assigned trials from strategy through execution. You will coordinate across feasibility, regulatory, site contracts, and clinical operations to ensure timely activation and TMF readiness.

Ideal candidates bring 8+ years in clinical research, expertise in start-up dependencies and regulatory submissions, and a proven ability to manage multiple trials across countries within