Senior Clinical Trial Manager
About The Position
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 Senior Clinical Trial Manager is primarily responsible for 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 all 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.
Requirements
- Manager Level: Bachelor’s degree or equivalent in Life Sciences with at least 6 years of clinical operations experience in the pharmaceutical industry with at least 1 year experience managing industry-sponsored pharmaceutical clinical studies as a sponsor employee
- Senior Manager Level: Bachelor’s degree or equivalent in Life Sciences with at least 8 years of clinical operations experience in the pharmaceutical industry with 3+ years’ experience managing industry sponsored pharmaceutical clinical trials as a sponsor employee
- Significant knowledge of GCP/ICH guidelines and the clinical development process
- Ability to plan, organize and conduct clinical studies with minimum oversight
- Significant experience managing CROs and other vendors and assessing performance
- Experience leading, managing, or mentoring clinical operational staff and cross-functional teams
- 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 team
- Able to solve problems under pressure
- Self-motivated and able to work effectively in a matrix/team environment
Nice To Haves
- Experience supporting Phase 1 and 2 clinical trials is preferred
- Oncology experience is highly preferred
Responsibilities
- Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
- Independently develop study timelines, key deliverables, and risk/mitigation strategies
- Lead selection and performance management of CROs and other ancillary vendors during study start-up, conduct, and close-out
- Plan and lead study team meetings
- Lead the development of study materials (e.g., study plans, monitoring guidelines, site initiation visit materials, site tools and worksheets)
- Contribute to the content and review of study documents (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, product administration guidelines)
- Track and ensure optimization of site startup activities and activation, subject enrollment, data collection, and trial closeout
- Ensure accurate and timely execution of site visit monitoring reports
- Identify, select, and monitor performance of sites
- Negotiate and manage the budgets and payments for sites
- Develop and maintain strong working relationships with study investigators and site staff
- Manage investigational product release packages and investigational product accountability
- Coordinate with Clinical Supply Chain Operations regarding investigational product shipment to sites
- Oversee the Trial Master File according to ICH- GCP and SOPs
- May assist in clinical data review and query generation
- Collaborates closely with Clinical Operations, Clinical Development, Biometrics, Clinical Data Management, Regulatory Affairs, Translational Medicine, Clinical Supply Chain, Pharmacovigilance, and Clinical Quality Assurance
- Actively participate in and contribute to the development of department initiatives aimed at improving efficiency and best practices
Benefits
- Competitive Medical, Dental, and Vision plans
- 401k plan through Fidelity, with a 100% match up to their first 4% deferral
- Generous Paid Time Off policy
- Employee commuter benefits
- Cell phone stipend
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
101-250 employees
