Zoek naar een Omgevingsmanager voor het Metronet project van RET in Rotterdam. Betrokken bij integraal omgevingsmanagement en stakeholdercommunicatie binnen complexe infrastructurele projecten.
About the role
- Senior Manager overseeing clinical data management projects at Regeneron across multiple therapeutic areas. Supervising teams and ensuring quality and timely data management results.
Responsibilities
- Provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas
- Interacts with clinical counterparts for overall project planning and issue resolution
- Projects, allocates and prioritizes DM resources within the assigned therapeutic projects
- Supervises direct DM reports and manages all relevant DM activities
- Mentors junior data managers for skills advancement
- Reviews and approves for final archival of project documentation
- Designs and modifies CRF
- Contributes to development of Regeneron DM outsourcing strategies
- Ensures adequate management of CROs and vendors in the therapeutic projects
- Establishes goals, expectations and accountabilities for direct reports
- Responsible for coaching, handling training and leading the direct reports
Requirements
- Bachelor’s degree in mathematics, Science or a related field
- at least 8-10 or more years of clinical data management experience in biotech, pharmaceutical or health related industry
- Previous oncology and/or ophthalmology experience a plus
- Previous managerial experience is preferred
- directed and comfortable working in teams with the ability to work and operate independently within a tight time line environment
- High degree of creativity, latitude and attention to detail required
- Knowledge of all applicable regulations including; CFR, GCP, and ICH Guidelines
- Strong communication, leadership and business development skills required
- Proficient with appropriate EDC applications and Microsoft Office applications
- Software proficiency with CDMS required
- Experience with JMP and SAS a plus.
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) for eligible employees at all levels
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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