Clinical Research Director
2 weeks ago
Key Responsibilities
- Identify and qualify clinical sites, negotiate budgets and contracts to ensure successful study execution.
- Develop and lead the creation of clinical study protocols and reports, ensuring compliance with regulatory requirements.
- Collaborate with regulatory teams to prepare and submit FDA packages, ensuring timely and accurate submissions.
- Oversee clinical sites, central labs, and third-party vendors to resolve issues efficiently and effectively.
- Ensure clinical studies are completed on time and within budget, meeting project objectives.
Required Qualifications
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- Minimum 10 years of clinical research experience, with a focus on medical devices and IVD products.
- At least 5 years of experience with rapid self-test IVD products, with a strong understanding of FDA regulations.
- Proven ability to communicate effectively with regulatory agencies.
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