Mission
ClinicalResearchAssociateManagerSMM
Neural analysis suggests this role is
optimal for Manager candidates.
“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
Full Job Description
Role: Clinical Research Associate Manager SMM Type: Field - USA Direct functional line management of a group of Clinical Research Associates within US Site Management and Monitoring. Accountable for the successful execution of clinical trials including resource allocation, adherence to timelines and compliance with all SOPs, policies and regulatory requirements. Oversees project assignments, workload distribution and problem resolution with direct reports. Interacts with other team management and functions as needed. **Typical Accountabilities** * Responsible for performance management and development including talent development, coaching, mentoring and providing routine feedback. * Interviews, hires, develops and trains staff on AZ SOPs, policies and procedures. * Communicates regularly with contract staff managers to provide feedback on contract staff performance. * Evaluates and projects resource needs on an on-going basis based on portfolio. * Ensures the implementation of clinical studies through efficient allocation of CRAs. * Ensures close working relationship within US SMM including other CRA managers and Clinical Research Managers as well as other key internal/external stakeholders. * Responsible for ensuring adequate, timely and compliant monitoring, site management and oversight for assigned CRAs. * Conduct regular (twice annually) quality visits with each employee CRA. * Communicate with staff on program changes, policy changes, and priority shifts on a regular basis. * Be aware of issues affecting staff’s workload and efficiency. Collaborate with colleagues and US leadership team as needed for escalation and support for resolution. * Review and approve expenses; assure expense reports are being submitted on a timely basis and are in compliance with the company's policies. * Conduct regular staff meetings and participate in Management staff meetings. * Leads special initiatives as needed. * Partner with key operational sites to develop/enhance AZ relati
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