Senior Clinical Quality Manager

The Clinical Quality Manager is a working member of the clinical team focused on the delivery of quality clinical services to the company and Advanced Clinical customers. This position will provide support to functional areas in preparing for governance meetings, establishing, tracking and meeting KPIs, conducting risk assessment, and managing and mitigating risk during projects. They may also support clinical operations in providing training to certain roles. This role will also liaise with Compliance and Quality on internal audits, CAPAs, CAPA closure and audit finding resolution and remediation. As needed, the Clinical Quality Manager will develop, revise, and contribute to the improvement of polices, systems and procedures.

• Candidate must have efficient time management skills with ability to successfully direct competing priorities
• Demonstrate experience supporting governance, risk assessment, KPI development and tracking, root cause analysis and CAPA expertise
• Maintain GxP knowledge and expertise relevant to applicable local andinternational regulations
• Ensure Policies and SOPs are created, reviewed, revised, and approved according to the SOP review schedule as needed
• Ensure compliance with applicable GCPs through training, processes, and early issue identification and correction

• Drive a culture of continuous process improvement
• Participate in project team meetings when quality issues are escalated

• Education: Bachelor's or equivalent degree in a relevant field of study (including but not limited to Quality, Business, Regulatory Affairs, Health Care, Research, etc.) is required.
• A minimum of five years of experience in clinical operations for the clinical trial industry; preferably the CRO industry. Experience across CRO,FSP, and Staffing business development with the ability to understand the differences in sales cycles and customer interactions
• Excellent verbal and written communication, and presentation skills
• Excellent interpersonal and organizational skills with attention to detail
• Strong computer proficiency in MS Office including Outlook, Word, Excel, and PowerPoint
• Strong critical thinking, problem solving and analytical skills
• Ability to efficiently organize and prioritize tasks within a multifaceted framework and set deadlines
• Excellent documentation skills
• Ability to maintain excellent working relationships with a broad range of staff; all levels of management and within teams
• Ability to work well in a team environment but also independently without significant oversight; Flexibility in work hours and ability to travel
• Consultative and collaborative approach when dealing with customers and internal team members
• Listens well, receives feedback and seeks input from others.

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