Associate Clinical Trial Manager

POSITION SUMMARY

The Associate Clinical Trial Manager is primarily responsible for supporting the operational management and oversight of Umoja’s clinical studies. This individual will work closely with Clinical Operations leadership, Medical Director(s), other cross-functional team members, and designated CROs to ensure the successful completion of assigned clinical study activities and project deliverables within specified quality, time, and cost parameters.

The ideal candidate brings clinical operations expertise in biotech and the ability to thrive in a fast-paced, entrepreneurial environment.

This role is ideally based out of our Seattle, WA location and is onsite at least 2 days/week. We are open to remote work within the US for the right candidate.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
• Leads specific aspects of assigned clinical trial(s) and demonstrates a high level of knowledge of Clinical Operations’ methodologies, organizational, project management and leadership capabilities
• Supports selection and performance management of CROs and other ancillary vendors during study start-up, conduct, and close-out
• May act as a country lead for large global studies, working under the guidance of the Clinical Trial Manager/Clinical Operations Leadership
• Tracks and ensures optimization of site startup activities and activation, subject enrollment, data collection, and study closeout
• Contributes to the content and review of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, site initiation visit materials, site tools and worksheets, product administration guidelines)
• Coordinates, files and tracks the distribution of study documents and creates and updates study reports
• Assists in the set up and oversight of the Trial Master File according to ICH- GCP and company SOPs
• Ensures all trial documentation is in a state of audit readiness
• Identifies, selects, and monitors performance of investigational sites
• Ensures accurate and timely site visit monitoring reports
• Develops and maintains strong working relationships with trial investigators and staff
• Assists in management of budgets and payments for investigative sites
• Coordinates with Clinical Supply Chain Operations regarding investigational product shipment to sites
• Manages investigational product release packages and investigational product accountability
• May assist in clinical data review and query generation
• Actively participates in and contributes to the development of department initiatives aimed at improving efficiency and best practices
• Collaborates closely with Clinical Operations, Clinical Development, Biometrics, Clinical Data Management, Regulatory Affairs, Translational Medicine, Clinical Supply Chain, Pharmacovigilance, and Clinical Quality Assurance
• Performs administrative tasks to support Clinical Operations and other team members, as needed

The successful candidate will have:

• Bachelor’s degree or equivalent in Life Sciences with at least 3-5 years of clinical operations experience in the pharmaceutical industry with significant knowledge of GCP/ICH guidelines and the clinical development process
• Strong organizational skills and the ability to balance changing priorities
• Strong interpersonal and communication (written and verbal) skills
• Demonstrated ability to work independently and as part of a multi-functional study team
• Able to solve problems under pressure
• Self-motivated and able to work effectively in a matrix/team environment

Preferred Qualifications:  

• Experience supporting Phase 1 and 2 clinical trials is preferred
• Oncology experience is preferred

Physical Requirements:  

• Ability to travel as needed (approximately 20%)
• Ability to work onsite 2 days/week at our Seattle, WA office
• Ability to sit for prolonged periods of time

Salary Range: $110,000 - $130,000

Develops in vivo CAR-T cell therapies to treat cancer.