Bayside Solutions ยท 1 day ago
Clinical Trial Manager
Bayside Solutions is seeking a Clinical Trial Manager to oversee clinical trials, particularly in the early phases of small molecule drug development. The role requires extensive experience with regulatory bodies and a strong background in managing neurological products.
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Qualification
Required
7-10+ years of experience
Good with remote - Prefers Midwest or East Coast, but open to West Coast
Experience with FDA, EU & Japan Regulatory bodies
Small Molecule experience - all phases (specifically early phase) (not injectables) P1 - Approval/commercialization
Highly prefer experience with Neurological products
Not afraid to ask questions
Wear multiple hats
Can think/learn by themselves
Willing to work outside of the job description
Can handle difficult recruiting/retention for patients
Preferred
Quality leadership
Clinical trial management
Senior clinical operations
Small molecule drug development
Early-phase clinical trials
Phase 1-approval experience
Neurological product experience
FDA regulations
EU regulatory requirements
Japan regulatory experience
Global regulatory compliance
Patient recruitment and retention
Cross-functional collaboration
Adaptability
Independent problem-solving
Ability to wear multiple hats
Strong communication
Proactive learning
Remote work experience