Senior Clinical Trial Manager

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.
• Proactively identify potential operational risks across assigned trials and develop and implement mitigation and contingency plans.
• Support analysis, troubleshooting, and interpretation of clinical data; prepare reports and communicate findings to internal stakeholders.
• Stay abreast of industry developments, regulatory changes, and advancements in clinical research methodologies to continuously improve trial execution.
• Build and maintain effective working relationships with cross-functional teams, external partners (CROs, vendors), and study sites to ensure alignment on trial objectives.
• Serve as a senior operational resource within the clinical team.

Qualifications

• Bachelor’s Degree in life sciences, pharmacology, or related field. Advanced degree (MSc., Ph.D., PharmD, MD) in life sciences, pharmacology, or related field is welcome but not required.
• 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.
• 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.
• 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.

Pay

The salary range for this position is $145,000- $165,000/year. Competitive equity package applies. Pay offered may vary depending on job-related knowledge, skills, and experience.