Regeneron
Healthcare
Manager,ClinicalStudyLead
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“Manager, Clinical Study Lead at Regeneron. Skills: Clinical trial management, Global study execution, Budget management, Vendor management. Accountable for global execution of clinical trials. Manage study timelines”
What You'll Achieve.
Ensure study conduct compliance; Ensure CROs alignment; Ensure vendors alignment; Accurate budget management; Accurate scope change control; Monitor site activation; Monitor monitoring visits; Implement patient recruitment strategies; Implement patient retention strategies; Monitor data entry; Monitor query resolution; Manage database lock; Manage contract reconciliation; Manage budget reconciliation; Manage TMF reconciliation; Manage study drug reconciliation; Improve CTM SOPs
Industry & Context.
Issue resolution; Corrective actions; Risk assessment; Deviation response
4 days per week on site, 25% Travel may be required
What They're Looking For.
Must Have
Bachelor’s degree, Six years relevant industry experience, Extensive budget management, Proven ability to build productive study teams, Demonstrated vendor management experience, Technical proficiency with trial management systems, Proficiency with Microsoft applications, Proficiency with platforms such as IVRS/IWRS, Proficiency with EDC, Experience in global clinical trial operations, Developing protocols, Solid knowledge of ICH/GCP, Knowledge of relevant regulatory guidelines, Effective project management skills, Cross-functional team leadership skills, Organizational skills, Ability to understand operational strategic direction, Ability to implement operational strategic guidance
Nice to Have
Experience with key study documentation
What You'll Do.
Accountable for global execution of clinical trials
Manage study timelines
Ensure study conduct compliance
Drive process improvement initiatives
Lead cross-functional study team
Oversee execution against timelines
Oversee execution against deliverables
Oversee execution against budget
Raise issues to Program Operations Lead
Implement corrective actions
Provide operational input into feasibility assessments
Oversee site evaluation
Lead investigator meeting preparation
Lead investigator meeting execution
Contribute to study documentation
Oversee study systems set-up
Oversee study systems maintenance
Ensure compliance with registry requirements
Identify outsourcing needs
Lead vendor engagement
Lead vendor contracting
Ensure CROs alignment
Ensure third-party vendors alignment
Provide input into baseline budget
Provide input into timeline development
Ensure accurate budget management
Ensure scope change control
Lead study-level risk assessment
Monitor site activation
Monitor monitoring visits
Oversee patient recruitment strategies
Oversee patient retention strategies
Respond to deviations
Monitor query resolution
Manage study close-out activities
Manage reconciliation of vendor contracts
Manage reconciliation of budget
Manage reconciliation of TMF
Manage reconciliation of study drug
Contribute to clinical study report writing
Facilitate study-level lessons learned
Assign tasks to CTM staff
Manage CTM work assignments
Manage CTM performance
Manage CTM recruitment
Manage CTM professional development
Manage CTM compliance
Provide CTM study support
Provide CTM study oversight
Participate in cross-functional process improvement
Participate in departmental process improvement
Identify innovative approaches to study execution
Assist with masked investigational product
Set up unmasked trial master file
Manage unmasked trial master file
Act as point of contact for IVRS issues
Support oversight of unmasked clinical monitoring
How You'll Work.
Team & Collaboration
Cross-functional study team; Cross-functional process improvement; Departmental process improvement
Communication Scope
Executive presentations; Technical documentation; Client meetings
Process & Methodology
Project management, Timeline management, Budget management, Scope change control, Risk assessment, Vendor management, Contract management, Database lock, TMF management
Full Job Description
**Build our future together:** The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out. You are accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. **When & where:** * Work Location: Armonk, NY, Warren, NJ, Uxbridge, UK * Hybrid; 4 days per week on site * 25% Travel may be required **Discover your role:** * 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 while raising issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implementing corrective actions * Provides operational input into protocol development; leads feasibility assessments to select relevant regions and countries; oversees or conducts site evaluation and selection; and 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 pe
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