Senior Clinical Research Manager
New
USAFull-TimeSenior
Salary$150,000 — $165,000 USD
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Job Details
- Experience
- Minimum of 10 years' clinical research experience
- Required Skills
- GCP
Requirements
- Bachelor's degree in related medical field.
- Minimum of 10 years' clinical research experience, with demonstrated ownership of study execution.
- Experience working within a Pharmaceutical, Vitamin Mineral Supplement category or wellness brand.
- Hands-on experience managing and executing development studies in-house.
- Direct experience authoring protocols, ICFs, and CRFs.
- Proven experience managing IRB submissions and approvals independently.
- Advanced presentation skills, ability to influence and articulate findings in a compelling way.
- Strong working knowledge of GCP, ICH guidelines, and human subjects research requirements.
- Hands-on experience designing and managing clinical data systems (EDC, eTMF).
- Experience operating without CRO support or in lean clinical environments.
- Ability to travel for site visits within California up to 20%.
Responsibilities
- Develop and manage study timelines, budgets, and resource plans.
- Coordinate with internal stakeholders (e.g., product, regulatory, marketing, data) to align study objectives with business goals.
- Proactively identify risks and implement mitigation strategies.
- Author core clinical study documents, including protocols, informed consent forms (ICFs), and case report forms (CRFs).
- Lead full study lifecycle execution from startup through closeout.
- Prepare and manage IRB submissions, amendments, and continuing reviews.
- Ensure studies are conducted in compliance with GCP and applicable regulatory and ethical guidelines.
- Design and oversee clinical data systems, including EDC and eTMF.
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