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Responsible for ensuring completeness of Site Essential Document Packages and Site Regulatory Packages for clinical study initiation and activation. Engages with regulatory representatives and manages document tracking and approvals, training, and compliance with standards.

The Senior Clinical Research Associate oversees site management and monitoring for clinical trials, ensuring compliance with GCP, patient safety, and quality execution of studies. Responsibilities include managing operational aspects, training site personnel, addressing protocol issues, and conducting monitoring activities.

The Senior Biomarker Data Curator manages clinical specimen inventory data, supports data transfers, analyzes information, and ensures quality control in data management activities.

Collaborate with Project Lead to develop, validate, and maintain datasets and statistical outputs for clinical trials, ensuring compliance with standards and accuracy in programming.

The Sr. Clinical Research Associate manages sites for clinical trials, ensuring compliance with protocols and regulations, conducting monitoring visits, and collaborating with study teams.

Manage Regulatory CMC submissions, develop regulatory plans, coordinate projects, assist in health authority engagements, and ensure compliance with standards.

The Consultant will provide statistical expertise in meta-analysis, collaborate on evidence generation plans, and guide junior staff in a multi-disciplinary research environment.

Lead and coordinate global labeling initiatives, ensuring compliance with regulatory requirements. Manage label governance and support product lifecycle management across multiple markets.

The Market Development Analyst will generate marketing campaigns and analyze opportunities to increase client awareness, while tracking activities in the CRM system.

The Investigator Financial Analyst II manages budget forecasts for clinical projects, analyzes financial impacts, and collaborates with teams to ensure project financials are on target.