Senior Clinical Trial Manager

Umoja Biopharma

Senior Clinical Trial Manager overseeing clinical operations and study management at biotech company Umoja Biopharma. Collaborating with cross-functional teams to ensure successful clinical study completion.

Posted 4/25/2026full-timeSeattle • Washington • 🇺🇸 United StatesSenior💰 $125,000 - $175,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

Medical, Dental, and Vision plans
401k plan with 100% match up to first 4% deferral
Generous Paid Time Off policy
Employee commuter benefits
Cell phone stipend

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical operationsstudy protocol developmentrisk mitigation strategiesCRO managementstudy materials developmentdata collectionbudget managementinvestigational product accountabilityclinical data reviewGCP/ICH guidelines

Soft Skills

organizational skillsinterpersonal skillscommunication skillsproblem-solvingself-motivationteam collaborationleadershipmentoringtime managementadaptability