Manager, Clinical Study Lead

Regeneron Pharmaceuticals•Armonk, NY

7d•$128,600 - $210,000•Hybrid

About The Position

The Manager, Clinical Study Lead is responsible for the global execution of assigned clinical trials, from study design through execution to study close-out. This role involves managing study timelines, budgets, and ensuring compliance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. The position applies to both internally sourced studies and those outsourced to Clinical Research Organizations (CROs), with the balance of direct leadership versus oversight varying accordingly. The role also contributes to ongoing process improvement initiatives.

Requirements

Bachelor’s degree
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 is required, 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
Solid knowledge of ICH/GCP and relevant regulatory guidelines and directives
Effective project management, cross-functional team leadership, and organizational skills
Ability to understand and implement the operational strategic direction and guidance for respective clinical studies

Nice To Haves

Experience with Phase IV /RWE preferred

Responsibilities

Leads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight.
Oversees execution against planned timelines, deliverables, and budget.
Raises issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implements corrective actions.
Provides operational input into protocol development.
Leads feasibility assessments to select relevant regions and countries.
Oversees or conducts site evaluation and selection.
Leads investigator meeting preparation and execution.
Oversees and contributes to study documentation, including case report forms, data management plan, monitoring plan, monitoring oversight plan, project-specific training plan, data review plan, statistical analysis plan, and related materials.
Oversees set-up and maintenance of study systems (e.g., CTMS, TMF) and ensures compliance with clinical trial registry requirements.
Identifies outsourcing needs and leads vendor engagement, contracting, and management; ensures CROs and third-party vendors are aligned and delivering per scope of work.
Provides input into baseline budget and timeline development and management; ensures accurate budget management and scope change control for internal and external studies.
Leads study-level risk assessment and mitigation.
Monitors site activation and monitoring visits and acts on deviations.
Leads development and oversees implementation of patient recruitment and retention strategies and responds to deviations from plan.
Monitors data entry and query resolution against agreed metrics.
Manages study close-out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability.
Contributes to clinical study report writing and review.
Facilitates study-level lessons learned.
Assigns tasks to Clinical Study Management staff and supports their deliverables.
Directly supervises CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight).
Recommends and participates in cross-functional and departmental process improvements.
Identifies innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs.
May be assigned unmasked tasks for studies, which may include assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring.