Manager, Clinical Study Lead

Regeneron Pharmaceuticals • Warren, MI

5d

About The Position

The Manager, Clinical Study Lead is accountable, with moderate oversight, for the global execution of assigned smaller or less complex clinical trials, from study design through execution and closeout. The role is accountable for study timelines and budget and for ensuring conduct complies with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. Responsibilities may cover internally sourced studies and studies outsourced to Clinical Research Organizations (CROs), with the balance of direct leadership and oversight varying accordingly. The role also contributes to and drives process improvement initiatives.

The position leads cross-functional study teams and serves as the primary point of contact for leadership and oversight. It oversees study execution, documentation, systems, vendors, timelines, budgets, risks, recruitment, data quality, and closeout. The role also assigns work to Clinical Study Management staff and directly supervises CTM staff, including work assignments, performance management, recruitment, professional development, coaching, mentoring, training, compliance, and study support.

The position may be assigned unmasked study tasks, including assistance with masked investigational product, setup and management of an unmasked trial master file, review of unmasked data in the electronic data capture system, serving as the point of contact for IVRS issues, and supporting oversight of unmasked clinical monitoring. Work locations listed are Armonk, NY; Warren, NJ; and Cambridge, MA. Travel of up to 25% may be required.

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, including Project, PowerPoint, Word, and Excel, as well as 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.

Responsibilities

• Lead cross-functional study teams responsible for clinical study delivery and serve as the primary point of contact for leadership and oversight.
• Oversee study execution against planned timelines, deliverables, and budget; raise conduct, quality, timeline, and budget issues to the Program Operations Lead and stakeholders; and implement corrective actions.
• Provide operational input into protocol development and lead feasibility assessments to select relevant regions and countries.
• Oversee or conduct site evaluation and selection, and lead investigator meeting preparation and execution.
• Oversee and contribute to study documentation, including case report forms, data management plans, monitoring plans, monitoring oversight plans, project-specific training plans, data review plans, statistical analysis plans, and related materials.
• Oversee the setup and maintenance of study systems, such as CTMS and TMF, and ensure compliance with clinical trial registry requirements.
• Identify outsourcing needs and lead vendor engagement, contracting, and management; ensure CROs and third-party vendors are aligned and deliver according to the scope of work.
• Provide input into baseline budget and timeline development and management; ensure accurate budget management and scope change control for internal and external studies.
• Lead study-level risk assessment and mitigation.
• Monitor site activation and monitoring visits, and act on deviations.
• Lead development and oversee implementation of patient recruitment and retention strategies, respond to deviations from plan, and monitor data entry and query resolution against agreed metrics.
• Manage study closeout activities, including database lock, reconciliation of vendor contracts and budget, TMF, and study drug accountability.
• Contribute to clinical study report writing and review, and facilitate study-level lessons learned.
• Assign tasks to Clinical Study Management staff and support their deliverables.
• Directly supervise CTM staff, including work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support and oversight.
• Recommend and participate in cross-functional and departmental process improvements; identify innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs.
• When assigned, perform unmasked study tasks, potentially including assistance with masked investigational product, unmasked TMF setup and management, review of unmasked EDC data, serving as the IVRS issues point of contact, and supporting oversight of unmasked clinical monitoring.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, a 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager