Clinical Study Manager Senior
4 days ago
We are seeking an experienced Associate Clinical Study Manager to join our team at BioMarin. The ideal candidate will have a strong background in clinical research and a passion for driving innovative medical solutions.
About the Role:
This is an exciting opportunity for a highly motivated individual to take on a leadership role within our Clinical Science team. As an Associate Clinical Study Manager, you will be responsible for overseeing clinical programs across various phases, from proof-of-concept to Phase 3 and BLA/NDA/MAA filing. You will work closely with our team to ensure excellence in clinical trial conduct, data analysis and interpretation, publication preparation, and safety monitoring.
Key Responsibilities:
* Develop key documents to support trial execution and regulatory submission
* Support the design, update and implementation of Clinical Development Plans (CDPs)
* Develop scientific rationale for methods, design and implementation of clinical protocols, data collection systems and final reports
* Stay up-to-date with advances in literature in therapeutic/disease area including mechanism of action, diagnostic tests, treatment, drug development trends, and regulatory requirements
Competencies:
* Provide context and articulate key messages effectively
* Anticipate risks or issues to program or business and take necessary steps to mitigate or address
* Proactively critique clinical and scientific evidence and research and interpret how findings may impact BioMarin clinical development plans and publication plans
Education and Experience:
* MD, MD/PhD (or equivalent) degree required
* 2+ years of relevant experience in genetic diseases, metabolic diseases, specialty care, and/or rare diseases desired
Salary Information:
The estimated salary range for this position is $120,000 - $160,000 per year, depending on location and experience.
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