Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Senior Manager managing clinical science projects within Regeneron Genetics Medicine. Overseeing clinical trials and contributing to regulatory documentation and compliance.
Responsibilities
- Supports the cross-functional study team on various activities
- Contributes to the writing of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs)
- Assists with identifying collaborators/advisors and organizes consultations
- Represents the clinical function on clinical study teams
- Works alongside Clinical Trial Manager for day-to-day clinical input
- Drafts clinical sections in regulatory and clinical documents
- Reviews study related documents
- Trains and supports study team and CRO personnel
- Assists with medical monitoring and writing safety narratives
- Organizes steering committees, advisory boards, and data safety monitoring boards
- Identifies program or data risks and implements strategies
- Ensures compliance with guidelines for clinical safety
- Provides background literature searches in support of clinical strategy
Requirements
- Bachelor’s degree
- Ph.D., PharmD. or Master’s degree in biomedical subject
- 8 years of clinical research/development 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)
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Research Coordinator overseeing clinical studies for musculoskeletal injuries in military health. Assisting with project planning and coordination while ensuring compliance with protocols and regulations.
Overseeing and administering clinical research studies and managing study budgets for military health research. Coordinating project planning and ensuring compliance with regulatory requirements.
Senior Biostatistician coordinating clinical trials at Parexel. Leading project teams and ensuring statistical quality in clinical research.
Centralized Clinical Trial Manager at ICON responsible for reviewing clinical trial site visit reports and ensuring quality standards. Act as a liaison for timely resolution of issues.
Clinical Research Nurse Coordinator managing clinical research operations at Duke's Trauma, Acute & Critical Care Division. Supervising nursing care and ensuring accuracy in data management.
Clinical Research Coordinator managing clinical trials at Emory University. Overseeing research projects, providing guidance, and ensuring compliance with protocols and regulations.
Senior Clinical Trial Manager managing Phase 1 clinical research studies and collaborating with cross - functional teams in a global biopharmaceutical environment.
HR Manager for Clinical Research Units lead engagement strategies at Fortrea. Partnering closely with site leadership in clinical environments in Dallas, TX or Madison, WI.
Clinical Trial Manager overseeing clinical trials managing operations and compliance in Brazil at IQVIA. Ensuring adherence to protocols and managing country - specific requirements.