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 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 is required Hands‑on experience managing and executing development studies in‑house; startup experience is a plus 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 strongly preferred Ability to travel for site visits within California up to 20% Certifications & Qualifications Bachelor's degree in related medical field #J-18808-Ljbffr
