Global Study Start-Up & Activation Lead

CTI; Raleigh (NC); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Health benefits

Paid parental leave

Job summary

CTI is seeking a Senior Study Start-Up Lead to drive global site activation strategies across multiple trials and countries. You will coordinate with feasibility, regulatory, contracts, and project management teams to ensure timely activation and delivery of study milestones.

This role requires deep knowledge of ICH/GCP, TMF readiness, and strong communication with senior leadership and sponsor teams. A scientific or healthcare degree and extensive clinical research experience are essential.

Qualifications

• Requires leading global study start-up and site activation across multiple trials and countries.
• Ability to forecast milestones and manage dependencies in complex trials.
• Strong communication skills for senior sponsor updates and governance.

Responsibilities

• Develop and lead global study start-up and site activation strategy, including milestones and mitigation plans.
• Maintain country/site activation plans aligned with sponsor timelines and project scope.
• Act as primary operational owner for start-up status, risks, and recovery planning.

Skills

Global study start-up

Site activation strategy

Cross-functional collaboration

Risk assessment & mitigation

Communication to senior leaders

Influence without authority

Multi-trial management

Documentation & records

Decision making & problem solving

CTI SOPs & regulatory knowledge

Site activation processes & TMF

Clinical trial management systems

Education

Bachelor's degree in scientific/healthcare or related discipline

8 years clinical research experience in start-up/site activation/clinical operations

Tools

Clinical trial management systems

Start-up tracking tools

Job description

CTI is seeking a Senior Study Start-Up Lead to drive global site activation strategies across multiple trials and countries. You will coordinate with feasibility, regulatory, contracts, and project management teams to ensure timely activation and delivery of study milestones.

This role requires deep knowledge of ICH/GCP, TMF readiness, and strong communication with senior leadership and sponsor teams. A scientific or healthcare degree and extensive clinical research experience are essential.