Senior Clinical Research Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Develop and oversee timelines, budgets, and resource plans for studies.

• Collaborate with internal teams (e.g., product, regulatory, marketing, data) to ensure study objectives align with business goals.

• Proactively identify potential risks and implement strategies for mitigation.

• Author essential clinical study documents, including protocols, informed consent forms (ICFs), and case report forms (CRFs).

• Lead the execution of the entire study lifecycle from initiation to closeout.

• Prepare and manage Institutional Review Board (IRB) submissions, amendments, and ongoing reviews.

• Ensure compliance of studies with Good Clinical Practice (GCP) and relevant regulatory and ethical guidelines.

• Design and oversee clinical data systems, including Electronic Data Capture (EDC) and electronic Trial Master File (eTMF).

⛳️ Requirements

• Bachelor's degree in a relevant medical field.

• At least 10 years of clinical research experience, demonstrating ownership of study execution.

• Required experience in a Pharmaceutical, Vitamin Mineral Supplement category, or wellness brand.

• Practical experience managing and executing development studies in-house; experience with startups is a plus.

• Direct experience in authoring protocols, ICFs, and CRFs.

• Proven track record of independently managing IRB submissions and approvals.

• Advanced presentation skills, with the ability to influence and convey findings effectively.

• Strong understanding of GCP, ICH guidelines, and requirements for human subjects research.

• Hands-on experience in designing and managing clinical data systems (EDC, eTMF).

• Experience working without CRO support or in lean clinical environments is highly preferred.

• Willingness to travel within California for site visits up to 20% of the time.

🏝️ Benefits

• Fully remote work experience.

• Comprehensive medical, dental, and vision package, including a Flexible Spending Account (FSA) program.

• 401K plan with employer matching.

• Quarterly Bonus Program.

• Flexible Paid Time Off (PTO).

• Two company-wide wellness breaks every day.

• Complimentary lunch every Tuesday and Thursday via Seamless/Grubhub.

• Monthly wellness stipend.

• Monthly internet stipend.

• Monthly cell phone stipend.

• Annual learning and development stipend.

• Free membership to a meditation app (Headspace).

• Free subscription to Nutrafol.

• Discounts and benefits for pet insurance.