Responsibilities
- Independently manage all operational aspects of assigned Phase I clinical trials from startup through closeout, ensuring adherence to protocols, regulatory requirements, and ethical standards.
- Oversee Contract Research Organizations (CROs) and vendors to ensure all clinical operations are carried out in alignment with the study’s goals, budget, and timelines.
- Develop and maintain study-level operational plans, including monitoring plans, communication plans, and risk management plans.
- Ensure robust patient recruitment and retention strategies are in place and effectively executed in partnership with sites and CROs.
- Play a key role in the company-wide rollout of Veeva Vault, serving as a primary operational user and subject matter resource for clinical trial management, eTMF, and CTMS configuration; partner with IT and clinical leadership to drive adoption, define workflows, and train internal and external stakeholders.
Requirements
- Bachelor’s Degree in life sciences, pharmacology, or related field.
- 8 years of direct experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry. A combination of education and experience will be considered.
- Good working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other regulatory requirements in clinical research.
- Familiarity with the IND and CTA filing process.
- Ability to travel up to 20% per month as needed to oversee clinical trials at investigator sites, onsite meetings with vendors and conferences
Nice to Have
- Advanced degree (MSc., Ph.D., PharmD, MD) in life sciences, pharmacology, or related field is welcome but not required.
- 2-3 years of experience in phase 1 clinical research and operations within the pharmaceutical or biotechnology industry, with experience in immunology and/or dermatology studies being a plus.
Compensation
The salary range for this position is $145,000- $165,000/year. Competitive equity package applies.
Work Arrangement
Hybrid — Vancouver, WA, Remote/Hybrid (US-based)
Additional Information
- Legal authorization to work in the United States is required.
- Ability to travel up to 20% per month as needed to oversee clinical trials at investigator sites, onsite meetings with vendors and conferences.
- Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which they have applied should make a request to the recruiter or hiring manager, or contact hiring@absci.com.
