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 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 The successful candidate will have: 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 Preferred Qualifications: Experience supporting Phase 1 and 2 clinical trials is preferred Oncology experience is highly 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 Manager Level Salary Range: $125,000 - $150,000 Senior Manager Level Salary Range: $150,000 - $175,000 Benefits Offerings Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. 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.