Mission
ClinicalResearchAssociateManagerSMM
“Clinical Research Associate Manager SMM at Mission. Skills: Clinical trial management, Line management, Performance management. Manage Clinical Research Associates. Execute clinical trials”
Industry & Context.
Problem resolution; Escalation; Support for resolution
15% travel
What They're Looking For.
Must Have
8 years clinical trial experience, 4 years site monitoring, Fluent English, ICH/GCP knowledge, Local regulations knowledge, Medical knowledge in AZ Therapeutic Areas, Basic drug development process understanding, Clinical study management understanding, Monitoring understanding, Study drug handling understanding, Data management understanding
Nice to Have
Study leadership preferred, Line management preferred, Basic GMP/GDP knowledge, 15% travel required
What You'll Do.
Manage Clinical Research Associates
Execute clinical trials
Oversee project assignments
Resolve problems with direct reports
Interact with team management
Manage staff performance
Provide routine feedback
Provide feedback on contract staff performance
Project resource needs
Implement clinical studies
Ensure CRA allocation
Maintain working relationships
Ensure compliant monitoring
Ensure site management
Conduct quality visits
Communicate program changes
Communicate policy changes
Communicate priority shifts
Address staff workload issues
Escalate issues for resolution
Approve expense reports
Conduct staff meetings
Participate in management meetings
Lead special initiatives
Develop AZ relationship with sites
Mentor new team members
Ensure compliance with ICH/GCP
Ensure compliance with AZ Procedural documents
Contribute to process improvements
How You'll Work.
Team & Collaboration
Interact with team management; Work with other CRA managers; Work with Clinical Research Managers; Collaborate with colleagues; Work with US leadership team; Partner with operational sites; Work with local Study Delivery Team
Process & Methodology
Clinical trial management, Resource allocation, Timeline adherence, Workload distribution
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