Associate Clinical Trial Manager

Associate Clinical Trial Manager Umoja Biopharma - 4.0 Seattle, WA Job Details $110,000 - $130,000 a year 1 day ago Benefits Commuter assistance Health insurance Dental insurance 401(k) Paid time off Cell phone reimbursement Vision insurance 401(k) matching Qualifications ICH guidelines Research regulatory compliance Data collection Full Job Description Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families. Umoja Biopharma - Your Body. Your Hope. Your Cure.

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 Benefits Offerings Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.