Natera
Biotech
Manager,ClinicalTrials
“Manager, Clinical Trials at Natera. Skills: Clinical trials management, Regulatory requirements, Vendor management. Manage clinical trials execution. Ensure timelines met”
What You'll Achieve.
Ensure study timelines met; Ensure study costs met; Ensure quality metrics met; Ensure compliance protocol; Ensure compliance SOPs; Ensure compliance regulatory requirements; Ensure vendor compliance; Ensure execution project deliverables
Industry & Context.
Identify problems; Identify solutions
Post offer criminal background check
What They're Looking For.
Must Have
Bachelor's degree life sciences, 8 years clinical research, 4 years managing clinical trials, 4-7 years supporting clinical trials, HIPAA/PHI privacy training, Human Subjects Protection training, GCP training
Nice to Have
Advanced degree, Managing CROs experience
What You'll Do.
Manage clinical trials execution
Ensure quality metrics met
Ensure vendor compliance
Manage study contracting
Manage payment process
Prepare informed consent
Develop study training
Deliver study training
Develop monitoring plans
Execute monitoring plans
Prepare protocol amendment
Prepare clinical report
Ensure correct CRFs content
Prepare completion guidelines
Train study coordinators
Manage clinical staff
Oversee clinical staff
Monitor trial progress
Provide status updates
Support sample management
Support prospective sample testing
Create culture of respect
Focus on project results
Participate in audits
How You'll Work.
Team & Collaboration
Investigative site personnel; CROs; Study vendors; Clinical Data Management; Cross functional team members; External collaborators; Research and development groups
Communication Scope
Written communication; Oral communication
Process & Methodology
Study timelines, Study costs, Quality metrics
Applying for this Manager, Clinical Trials role?
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