Senior Clinical Data Manager
Location
United States
Posted
3 days ago
Salary
$128.8K - $180.3K / year
Job Description
Job Requirements
- BS degree in a Biomedical Science or comparable field of study
- Bachelor's degree with a minimum of 8 years of global clinical data management experience, or a Master’s degree with a minimum of 6 years of experience
- Prior experience in a sponsor, CRO, or medical device company
- In-depth knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide coding dictionaries such as MedDRA
- Strong expertise in implementing and maintaining systems for global trials (Specifically, Medidata Rave)
- Proven leadership in managing full-cycle data management activities
- Experience with risk mitigation and data quality strategies
- In-depth knowledge of ICH-GCP, FDA/EMA regulations, and GCDMP
- Strong expertise in implementing and maintaining systems for global medical device trials (Class II/III or combination products)
- Excellent stakeholder management skills with cross-cultural sensitivity and global collaboration experience
- Strong experience in vendor management and system validation
- Excellent verbal and written communication skills and interpersonal skills
- Excellent analytical, organizational, and communication skills
- Ability to manage multiple priorities in a fast-paced environment
- Proficiency with clinical data systems and MS Office Suite
- Position may require some travel
- Candidates must be authorized to work in the U.S.
- Occasional meetings out of normal working hours will be required as this role supports a global team
Benefits
- Competitive salaries, annual bonus and 401(k) with company match
- Comprehensive medical, dental, vision coverage effective on start date
- 24/7 Employee Assistance Program
- Free live and on-demand Wellbeing Programs
- Generous Paid Vacation and Sick Time
- Paid Parental Leave and Adoption Assistance
- 12 Paid Holidays
- On-Site Child Daycare, Café, Fitness Center
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