Sr. Clinical Research Manager
Fully remote work flexibility within the United StatesFull-TimeManager
Salary150,000 - 165,000 USD per year
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Job Details
- Experience
- 10+ years
- Required Skills
- Project ManagementGCP
Requirements
- Bachelor’s degree in a medical, life sciences, or related field.
- 10+ years of clinical research experience with full ownership of study execution.
- Proven experience in pharmaceutical, nutraceutical (VMS), or wellness industry clinical research.
- Hands-on expertise in authoring protocols, ICFs, CRFs, and managing IRB submissions independently.
- Strong knowledge of GCP, ICH guidelines, and human subject research compliance requirements.
- Experience designing and managing clinical data systems such as EDC and eTMF platforms.
- Demonstrated ability to operate in lean environments without CRO reliance and manage end-to-end studies internally.
- Strong communication, presentation, and stakeholder management skills with ability to influence cross-functional teams.
- Willingness to travel up to 20% for site visits (primarily within California).
Responsibilities
- Lead the full lifecycle of clinical studies from protocol development and startup through execution, analysis, and closeout.
- Design and author key clinical study documents including protocols, informed consent forms (ICFs), and case report forms (CRFs).
- Develop and manage study timelines, budgets, and operational plans while proactively identifying and mitigating risks.
- Oversee IRB submissions, amendments, and continuing reviews to ensure ethical and regulatory compliance.
- Ensure all clinical research activities adhere to GCP, ICH guidelines, and applicable human subject research regulations.
- Design and manage clinical data systems, including EDC and eTMF platforms, ensuring data integrity and accessibility.
- Collaborate cross-functionally with internal teams to align study design with product, regulatory, and business objectives.
- Provide operational oversight for study execution and ensure high-quality, compliant research delivery.
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