Global Clinical Study Lead: Strategy & Delivery

BioSpace; Armonk (NY); On-site; USD 129,000 - 210,000; Full time

Job summary

Regeneron in Armonk, NY is seeking a Manager, Clinical Study Lead to drive global execution of clinical trials from design to closeout, ensuring timelines, budgets, and quality per SOPs and ICH/GCP. This role leads a cross-functional study team and oversees protocol development, site selection, and study documentation.

You will manage study systems (CTMS, TMF, EDC/IVRS), coordinate vendor relationships, and drive risk mitigation, recruitment strategies, and process improvements across global

Qualifications

• Bachelor's degree and at least six years of relevant industry experience.
• Extensive budget management expertise; proven ability to build productive study teams and collaborations; demonstrated vendor management experience.
• Strong technical proficiency with trial management systems and Microsoft applications including Project, PowerPoint, Word, Excel, and platforms such as IVRS/IWRS and EDC.
• Experience in global clinical trial operations, including developing protocols and key study documents; knowledge of ICH/GCP and regulatory guidelines; and effective project management, cross‑functional team leadership, and organizational skills.
• Ability to understand and implement the operational strategic direction for respective clinical studies.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversees execution against planned timelines, deliverables, and budget.
• Provides operational input into protocol development; leads feasibility assessments to select regions and countries; oversees site evaluation and selection; leads investigator meeting preparation and execution.
• Oversees and contributes to study documentation including CRFs, data management, monitoring plans, and related materials.
• Oversees setup and maintenance of study systems (CTMS, TMF) and ensures compliance with registry requirements.
• Identifies outsourcing needs and leads vendor engagement, contracting, and management; ensures CROs and third-party vendors are aligned with scope of work.
• Provides input into baseline budget and timeline development and management; ensures budget control for internal and external studies.
• Leads study-level risk assessment and mitigation, monitors site activation and monitoring visits, and oversees patient recruitment and retention strategies.
• Manages study close-out activities including database lock, vendor contract reconciliation, budget, TMF, and study drug accountability; contributes to clinical study reports.
• Assigns tasks to Clinical Study Management staff, supervises CTM staff, drives cross-functional process improvements, and seeks innovative CTM SOP enhancements.
• May perform unmasked tasks for studies, including management of unmasked trial master file and IVRS issues.

Skills

Budget management

Vendor management

Project management

Cross-functional leadership

ICH/GCP knowledge

Education

Bachelor's degree

Tools

CTMS

TMF

EDC

IVRS/IWRS

Microsoft Office

Job description

Regeneron in Armonk, NY is seeking a Manager, Clinical Study Lead to drive global execution of clinical trials from design to closeout, ensuring timelines, budgets, and quality per SOPs and ICH/GCP. This role leads a cross-functional study team and oversees protocol development, site selection, and study documentation.

You will manage study systems (CTMS, TMF, EDC/IVRS), coordinate vendor relationships, and drive risk mitigation, recruitment strategies, and process improvements across global