Senior Manager, Clinical Study Lead – Hematology-Oncology
Regeneron
full-time
Posted on:
Location Type: Hybrid
Location: Dublin • Ireland
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Job Level
Tech Stack
About the role
- Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact for leadership and oversight
- Provides operational input into protocol development
- Oversees 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.
- Ensures compliance with the clinical trial registry requirements
- Identifies outsourcing needs of the study and leads engagement, contracting and management of required vendors
- Provides input into baseline budget development and management
- Leads risk assessment and identifies risk mitigation strategies at the study level
- Monitors progress for site activation and monitoring visits and acts on any deviations from plan
- Monitors data entry and query resolution and acts on any deviations from agreed metrics
- Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
- Manages and oversees study close-out activities including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
Requirements
- Minimum of a Bachelor's degree
- Minimum of 8 years relevant clinical trial experience
- Exceptional interpersonal & leadership skills
- Advanced project management skills, cross-functional team leadership and organizational skills
- Strong budget management experience
- Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
- Knowledge of ICH/GCP and regulatory guidelines/directives
- Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents.
- Ability to build, lead and develop productive study teams and collaborations.
- Demonstrates expert knowledge and a data-driven approach to planning, executing, and problem-solving.
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)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial experienceprotocol developmentdata management planstatistical analysis planrisk assessmentdata quality managementbudget managementproject management
Soft Skills
interpersonal skillsleadership skillsorganizational skillscross-functional team leadershipproblem-solving skills