As a Project Manager, oversee AutoStore® projects from start to handover. Ensure clear communication with clients and internal teams, managing timelines and quality criteria.
About the role
- Leading the operational execution of large clinical trials for Regeneron while overseeing study teams and vendor management. Requires extensive clinical trial experience and leadership skills.
Responsibilities
- 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
- 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
- Provides operational input into protocol development
- Oversees and provides input to the development of study specific documentation
- Oversees set-up and maintenance of study systems
- Ensures compliance with the clinical trial registry requirements
- 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
- Oversees/conducts site evaluation and selection
- Leads investigator meeting preparation and execution
- Monitors progress for site activation and monitoring visits
- Leads the development of and oversees implementation of patient recruitment and retention strategies
- Monitors data entry and query resolution
- Ensures accurate budget management and scope changes for internal and external studies
- 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)
- Contributes to clinical study report writing and review
- Facilitates and contributes to study level lessons learned
- Assigns tasks to Clinical Study Management staff and supports their deliverables
- Responsible for identification of innovative approaches to clinical study execution
- May require 25% travel
Requirements
- minimum of a Bachelor's degree
- minimum of 8 years relevant clinical trial experience
- Exceptional interpersonal & leadership skills
- Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies
- Demonstrates expert knowledge and a data-driven approach to planning, executing, and problem solving
- Advanced communication skills via verbal, written and presentation abilities
- 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
- Strong budget management experience
- An awareness of relevant industry trends
- Ability to build, lead and develop productive study teams and collaborations
- Applies advanced negotiation and interpersonal skills to vendor management
- Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
- Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Advanced project management skills, cross-functional team leadership and organizational skills
- Line management experience
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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