Eximia Research is a fully Integrated research sites network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). Our premier, multidisciplinary wholly owned research sites located across country and known for excellent trial execution, rapid subject recruitment/enrollment and delivery of a quality data.
Responsibilities
Director, Clinical Quality Management for the Clinical Trial Site Network will be responsible for the management and operational oversight of the quality activities for the broader business and clinical trial site level to ensure the company conducts its trials to the highest quality and regulatory obligations and enhances performance through continuous improvements
Ensure Standard Operating Procedures (SOPs) and Internal Operating Procedures are reviewed periodically and advise on required updates to ensure compliance with ethical, regulatory and other relevant frameworks, making recommendations for improvement where appropriate
Identify appropriate staff SOP training requirements and maintain oversight of training to ensure all clinical trials staff are trained on SOPs
Ensure staff SOP training requirements are achieved for QA and
Implement and maintain a Quality Management System (QMS) in line with the Corporate QMS and take the lead in presenting it to internal stakeholders, pharmaceutical sponsors, and other partners
Build, manage, lead and motivate a QA program, ensuring that people with the right range of skills and experience are recruited and retained, and that their skills and professional capabilities are maximized
Ensure quality and operational compliance; act as a subject matter expert for quality investigations, documentation systems, training programs, internal/external audits, and vendor assurance programs
Develop and implement a risk-based and flexible approach to QA in compliance with applicable regulatory requirements
Generate and analyze weekly, monthly and quarterly metrics to track KPIs
Work with Operations team to implement, review and maintain tracking of incidents within the clinical trials, advising on CAPAs to be implemented and ensure completion in a timely manner
Lead the Audit Program management process, including assessment of internal and external (outsourced) operations, and active audit and regulatory inspections
Partner with functional areas in study data collection, analysis, and reporting activities that support quality improvement interventions, transparency, compliance with regulatory standards, and provide performance monitoring
Qualifications
MUST have 10 years' experience within Clinical Research AND Clinical Quality Management
Experience with managing a QMS
Experience selecting, validating and auditing vendors
Comprehensive understanding of GCP, CFR and ICH guidelines
Experience with managing clinical quality activities and in-depth knowledge of clinical operations
Experience in with clinical trial site/process audits and regulatory inspections
Experience in line management of employees
Experience translating Pharma/Sponsor needs for innovation and creative approaches to quality management