Global Study Start-Up & Activation Lead

Ctifacts; Raleigh, Northern (NC, KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work opportunities

Health benefits

Vacation packages

Paid parental leave

Tuition reimbursement

Job summary

CTI Clinical Trial and Consulting Services seeks a seasoned leader to drive global study start-up and site activation. You will set activation strategy, sequence countries/sites, and manage critical path dependencies, ensuring timely delivery across trials.

You will partner with Feasibility, Regulatory, Contracts, and Budgets teams to align plans with sponsor expectations. This role demands strong risk management, cross-functional influence, and robust governance communication.

Qualifications

• 8 years of clinical research experience with focus on study start-up and site activation.
• Experience leading global start-up across multiple trials and countries.
• Ability to forecast milestones, dependencies, and risks for activation plans.

Responsibilities

• Develop and lead global study start-up and site activation strategies.
• Establish activation plans aligned with sponsor expectations and timelines.
• Serve as operational lead for start-up status, risks, decisions and recovery.
• Partner with Feasibility, Regulatory, Contracts, and Budgets teams for readiness.
• Coordinate with PM and TMF teams to ensure milestone progress and reporting.
• Monitor metrics, data quality, and cycle-time risks and lead mitigations.
• Ensure compliance with ICH/GCP and CTI SOPs throughout start-up activities.

Skills

Study start-up leadership

Global activation strategy

Cross-functional alignment

Risk management

Project management

Executive communication

Stakeholder management

Decision making

Interpersonal leadership

Timeline forecasting

Education

Bachelor's degree in sciences

Tools

CTMS

Start-up tracking tools

Microsoft Office

Job description

CTI Clinical Trial and Consulting Services seeks a seasoned leader to drive global study start-up and site activation. You will set activation strategy, sequence countries/sites, and manage critical path dependencies, ensuring timely delivery across trials.

You will partner with Feasibility, Regulatory, Contracts, and Budgets teams to align plans with sponsor expectations. This role demands strong risk management, cross-functional influence, and robust governance communication.