Global Site Start-Up Lead - Strategy & Delivery

BioSpace; 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 the global execution of site activation for clinical trials. You will partner with cross-functional teams and CROs to mitigate risks, track milestones, and ensure compliant site start-up across multiple countries.

The role includes overseeing TMF documentation, country start-up strategies, and fast-track site initiation, with up to 25% travel.

Qualifications

• Experience in the clinical drug development process, with expertise in study start-up.
• Demonstrated vendor management experience in CRO/site start-up contexts.
• Technical proficiency in trial management systems (CTMS, TMF) and MS applications (PowerPoint, Word, Excel).

Responsibilities

• Develop and execute global site start-up strategy for each study, identifying dependencies and mitigating risks.
• Lead country-start-up planning and ensure timely regulatory submissions and TMF documentation.
• Oversee fast-track site initiation, site calls, document collection, and milestone tracking with cross-functional and CRO partners.
• Represent SSU in cross-functional teams and drive issue resolution and process improvements.
• Travel up to 25% as needed to support global site start-up activities.

Skills

CTMS proficiency

TMF proficiency

Vendor management

Cross-functional collaboration

MS Office (PowerPoint, Word, Excel)

Project management

Tools

CTMS

TMF

MS Office

Job description

Regeneron is seeking a Manager, Global Site Start-Up Lead (SSU Lead) to drive the global execution of site activation for clinical trials. You will partner with cross-functional teams and CROs to mitigate risks, track milestones, and ensure compliant site start-up across multiple countries.

The role includes overseeing TMF documentation, country start-up strategies, and fast-track site initiation, with up to 25% travel.