Clinical Quality Operations Manager, FSP
Fortrea · Durham, NC · 3 wk ago
ManagementFull-time
Responsibilities
- Operational Quality Management
- Risk-Based Quality Management (RBQM)
- Third Party Oversight
- Data Analysis and Process Improvement
- Inspection Preparation and Management
- Capa Management Support
Qualifications
- Minimum of 6 years of relevant experience in clinical research
- Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements
- Experience with delivering effective CAPA management solutions
- Experience with risk management tools and processes within the clinical quality framework
- Familiarity with on-site monitoring activities
- Detailed knowledge of all aspects of GCP guidelines and regulations
- Proven ability to identify, escalate, and mitigate risks proactively
- Strong understanding of participant safety and dose-escalation controls
- Proven ability to work in a team environment
- Strong interpersonal and communication skills
- Strong analytical skills
- Strong negotiation skills and ability to influence stakeholders across functions
- Strong planning and organizational skills
- Strong leadership and process skills