Global Site Start-Up Lead — Clinical Trials

Regulatory Jobs; Armonk (NY); On-site; USD 115,000 - 187,000; Full time

Job summary

Regeneron is seeking a Manager, Global Site Start-Up Lead (SSU Lead) to drive global site activation for clinical trials, coordinating with cross-functional teams and CROs to ensure compliant, timely submissions and study objectives.

You will develop site activation projections, monitor CRO performance, manage country start-up strategies, regulatory submissions, TMF documentation, and lead fast-track initiation and milestone tracking, with up to 25% travel.

Qualifications

• Experience in clinical drug development and site start-up processes.
• Ability to lead cross-functional teams and CROs to achieve study milestones.
• Knowledge of ICH-GCP guidelines and regulatory submissions.

Responsibilities

• Develop site start-up strategy and timelines for each study.
• Monitor CRO performance and mitigate risks impacting activation.
• Lead fast-track initiation, milestone tracking, and TMF documentation.

Skills

Interpersonal leadership

Data-driven planning

Project management

Regulatory knowledge

Cross-functional collaboration

Tools

CTMS

TMF

PowerPoint

Word

Excel

MS Office

Job description

Regeneron is seeking a Manager, Global Site Start-Up Lead (SSU Lead) to drive global site activation for clinical trials, coordinating with cross-functional teams and CROs to ensure compliant, timely submissions and study objectives.

You will develop site activation projections, monitor CRO performance, manage country start-up strategies, regulatory submissions, TMF documentation, and lead fast-track initiation and milestone tracking, with up to 25% travel.