Clinical Quality Operations Manager
Location
United States
Posted
6 days ago
Salary
$120K - $132K / year
Seniority
Senior
Job Description
Clinical Quality Operations Manager
Fortrea
• Responsible for process and performance management related to the delivery of the operational function(s), as assigned. • Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials. • Single point of contact for clinical trial teams for all activities associated with risk-based quality management (RBQM). • Perform a TA-level review of quality plans and risk mitigation approaches to identify any emerging signals or trends. • Responsible for ensuring comprehensive oversight of all activities delegated to third parties. • Facilitating and monitoring CTT oversight of vendors. • Developing, reviewing and revising quality agreements with business partners. • Ensuring essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organisations. • Facilitating and overseeing responses to audit and inspection observations as appropriate. • Analyzing data across therapy areas in order to identify signals and trends and then developing and implementing appropriate process improvement strategies. • Maintaining current regulatory inspection knowledge regarding GCP inspections by regulatory agencies worldwide. • Contributing to the development and/or revision of Sponsor policies, SOPs and training materials. • Developing the strategy for management/support for GCP inspections of Sponsor products.
Job Requirements
- Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.
- Profound knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.
- 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.
- Fluent in English, both written and verbal.
- Experience in Risk Management and Quality Management in Phase I.
- Relevant clinical research experience in a pharmaceutical company or CRO: Minimum of eight (8) years relevant clinical research experience in a pharmaceutical company/CRO.
- Thorough knowledge of drug development process.
- Thorough knowledge of relevant SOPs, ICH, and GCP guidelines.
- Thorough project management, change management, line management experience, and quality control experience highly desirable.
- Individual is familiar with on-site monitoring activities (including pre-study, initiation, routine monitoring, and closeout visits), with on-site monitoring experience being highly desirable.
- Relevant quality management experience: Detailed knowledge of all aspects of GCP guidelines and regulations.
- Demonstrated ability to separate critical from non-critical GCP issues.
- Demonstrated effectively balance quality and speed in complex situations.
- Relevant leadership and process skills: Demonstrated ability to work in a team environment.
- Demonstrated ability to work under pressure and requires minimal supervision.
- Strong interpersonal and communication skills.
- Strong negotiation skills and ability to influence stakeholders across functions.
- Strong analytical skills.
- Excellent planning and organizational skills.
- Excellent oral, written and presentation skills.
Benefits
- Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
- 401(K)
- Paid time off (PTO)
- Employee recognition awards
- Multiple ERG’s (employee resource groups)
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