Senior Manager, Clinical Study Lead, Internal Medicine

About the role

The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. You will be accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
• Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
• Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
• Provides input into baseline budget development and management; Provides input into baseline timeline development and management
• Leads risk assessment and identifies risk mitigation strategies at the study level; Leads the feasibility assessment to select relevant regions and countries for the study
• Makes sure progress for site activation and monitoring visits are on track and addresses any deviations from plan
• Develops and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan; Monitors data entry and query resolution and acts on any deviations from agreed metrics
• Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues
• Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
• May be assigned unmasked tasks for studies, which may include but is not limited to, 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
• Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight

Requirements

• A minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience
• We are seeking experience with line management as well as exceptional interpersonal and leadership skills
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization; Ability to influence and negotiate across a wide range of stakeholders
• Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
• We are seeking extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents
• Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies

Qualifications

• Must be able to travel up to 25%

Skills

• Strong leadership and interpersonal skills
• Experience with clinical trial management systems
• Ability to manage budgets and timelines
• Expertise in regulatory guidelines and standards
• Strong communication and negotiation skills

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit here.

Pay

$150,500.00 - $245,500.00 annually

Schedule

Hybrid; 4 days per week on site