Clinical Quality Assurance Manager

• Determine, negotiate and agree on in-house quality procedures, standards and supporting documentation including interpretation and implementation of quality assurance standard.
• Work with operations staff to establish adequate procedures, standards and systems. Draft quality assurance policies and procedures and ensure review and approval in conjunction with other groups that impact the work conducted by the clinical operations staff. Driving the timely completion of SOP updates.
• Identify training needs and organize training interventions to meet quality standards. Ensuring SOP curricula for roles within the group are current and accurate.
• Develop, recommend and monitor corrective and preventive actions to ensure that quality issues are resolved and prevented in future through proactive and coordinated employee training and process innovation.
• Plan and conduct audits related to clinical operations including, but not limited to, clinical vendor audits, study site Quality Assurance audits, Trial Master File (TMF) audits, and site and sponsor pre-inspection preparation. Document internal audits and other quality assurance activities. Prepare reports to communicate outcomes of quality activities.
• Acting as a catalyst for change and improvement in performance and quality across the group. Identify trends that could improve the quality of clinical studies and data collection processes.

Requirements:

• Minimum of 5 years of progressively responsible experience in clinical quality assurance within a medical device, pharmaceutical, biotechnology, CRO, and/or healthcare setting required.
• Minimum of 8 years clinical operations management experience.
• Previous experience establishing quality clinical programs is preferred.
• Experience in design and development of quality plans and audit plans preferred.
• Demonstrated analytical, negotiation, documentation, meeting management, and leadership skills are required.
• Demonstrated knowledge of clinical quality assurance processes including, but not limited to, planning and conduct of site and vendor audits, Good Clinical Practices (GCP), Good Documentation Practices (GDP), and Quality Management Systems (QMS) is required.
• Demonstrated ability to effectively interact with and collaborate at all levels in the organization and with external stakeholders, including effective interfaces at the senior management level.
• Strong interpersonal, verbal and written communication skills.
• Ability to form strong and constructive internal as well as external professional relationships.
• Detail oriented, excellent organizational and management skills.
• Must have the demonstrated core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
• Thorough knowledge of FDA guidelines and regulations, ICH guidelines and Good Clinical Practices (GCP) governing the conduct of clinical trials required.
• Ability to travel up to 20% of the time.