Lead Clinical Trial Manager

Absci • Vancouver, WA

98d • $145,000 - $165,000

About The Position

We are seeking a dynamic Clinical Research Operations Manager to lead our clinical research initiatives and manage the operational aspects of our clinical trials. This pivotal role combines the scientific expertise of clinical research with the organizational skills of operations management to ensure the efficient and effective execution of studies across various therapeutic areas meeting regulatory standards and company objectives. The ideal candidate will have a strong background in the life sciences, a deep understanding of clinical trial processes, and experience in regulatory affairs to oversee both the scientific and logistical elements of clinical research.

Requirements

• Bachelors Degree in life sciences, pharmacology or related field a must.
• Advanced degree (MSc., Ph.D., PharmD, MD) in life sciences, pharmacology, or related field preferred.
• Minimum of 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.
• Exceptional organizational, communication, and leadership skills, with the ability to manage multiple projects and teams in a fast-paced environment.
• Strong analytical and problem-solving abilities, with a meticulous attention to detail.
• Demonstrated capability to work collaboratively across various departments and with external partners to achieve objectives.
• Ability to work in a fast-paced environment and manage multiple projects simultaneously.
• Ability to travel up to 20% per month as needed to oversee clinical trials at investigator sites, onsite meetings with vendors, and conferences.

Responsibilities

• Develop and maintain effective working relationships with cross-functional teams, external partners (CROs, vendors), and study sites to ensure collaboration and alignment on trial objectives.
• Manage Contract Research Organizations (CROs) to ensure that all clinical operations are carried out in alignment with the study’s goals, budget, and timelines.
• Ensure robust patient recruitment and retention strategies are in place and effectively executed.
• Author, review, and maintain Standard Operating Procedures (SOPs) related to clinical research and operations ensuring high quality, compliance with the study protocol and regulatory requirements across all trials.
• Support design, implementation, and oversight of clinical trials from concept through completion, ensuring adherence to protocols, regulatory requirements, and ethical standards.
• Identify potential risks and implement contingency plans.
• Ensure accurate data collection, documentation, and record-keeping.
• Support analysis and interpretation of clinical data, prepare reports, and communicate findings to internal stakeholders and regulatory agencies.
• Stay informed about industry developments, regulatory changes, and advancements in clinical research methodologies to inform trial design and execution strategies.
• Responsible for the integrity, confidentiality, and security of all research data.

Benefits

• Medical, dental, and vision insurance.
• Unlimited vacation.
• Parental leave.
• Breakfast and lunch for onsite employees.
• Employee assistance program.
• Voluntary life and disability insurance.
• Annual bonus potential.
• 401(k) with a generous company match.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees