[Remote] Sr. Clinical Research Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a growing company dedicated to hair wellness, creating clinically tested products for hair reputed company. They are seeking a full-time Clinical Research Manager to reputed company the execution of clinical studies, ensuring compliance and managing resources effectively.
Responsibilities
- reputed company and manage study timelines, budgets, and resource plans
- Coordinate with internal stakeholders (e.g., product, regulatory, marketing, data) to reputed company 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)
- reputed company 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 reputed company clinical data systems, including reputed company and eTMF
Skills
- Bachelor's degree in reputed company medical field
- Minimum of 10 years' clinical research experience, with demonstrated ownership of study execution
- Experience working reputed company 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
- reputed company experience authoring protocols, ICFs, and CRFs
- Proven experience managing IRB submissions and approvals independently
- Advanced presentation skills, ability to influence and reputed company findings in a compelling way
- Strong working knowledge of GCP, ICH guidelines, and reputed company subjects research requirements
- Hands-on experience designing and managing clinical data systems (reputed company, eTMF)
- Ability to travel for site reputed company reputed company California up to 20%
- Experience operating without CRO support or in lean clinical environments strongly preferred
Benefits
- Fully remote work experience
- Comprehensive medical, dental, and reputed company package, including FSA program
- 401K with employer match
- Quarterly Bonus Program
- Flexible PTO
- Two company-wide wellness breaks every day
- Free lunch on us every Tuesday and Thursday reputed company Seamless/reputed company
- Monthly wellness stipend
- Monthly internet stipend
- Monthly cell phone stipend
- Annual learning & development stipend
- Free meditation app membership (reputed company)
- Free reputed company subscription
- Pet insurance discounts and benefits
reputed company