Manager Sr, Clinical Quality Assurance (GCP)

650-Clinical Admin-Post Market        ·       Aliso Viejo, California, USA          ·         Full time

Job ID: 10710BR
Job Title: Manager Sr, Clinical Quality Assurance (GCP)
Location: Aliso Viejo, California, USA
650-Clinical Admin-Post Market
$123,318 – $172,645 (Compensation could be higher based on education, experience, and skill sets)

Job Description

Responsible for planning, coordinating, and managing clinical audits, monitoring departmental due diligence activities; and developing clinical research systems and processes. Responsible for overseeing the planning and implementation of clinical quality audit schedule to ensure compliance with company, ICH/GCP, company SOP’s, and applicable regulatory requirements. When applicable, assist in filing compliance reports with regulatory bodies. Job duties:

• Build study level audit schedules and conduct site, vendor, study, and sponsor level audits.
• Manage vendor/contractors associated with audit initiatives.
• Ensure all processes of a clinical trial are conducted properly.
• Collaborate with cross-functional groups including, but not limited to, Regulatory, Quality, and complaint handling to ensure Clinical Operations adherence to company policies and regulations.
• Keep up to date with all related quality legislation and compliance issues and perform gap analysis and remediation strategy to implement within internal systems.
• Oversee internal and external auditing activities to ensure studies are conducted in accordance with sponsor protocols, GCP/ICH/ISO, industry guidelines, and agency regulations.
• Create quality risk management plan, audit schedules, and BIMO readiness plans for current clinical studies.
• Communicate any critical compliance risks noted from these activities to senior management.
• Manage the tracking and resolving of procedure, GCP and/or ISO deviations and manage Corrective Action/Preventative Action (CAPA) investigations.
• Ensure timely issuance of audit reports, audit observation forms, oversee audit response process, and drive audits to closure.
• Manage documented reviews and audit protocols, informed  consents, clinical study reports, investigator brochures, regulatory submission documents, and other essential study documents as assigned. 
• Manage and develop staff.
• Manage special projects and perform additional duties as assigned.

Qualifications

• Bachelor’s degree in related field or equivalent combination of education and experience.
• A minimum of eight (8) years of direct clinical quality assurance experience in FDA regulated industry, including a minimum of four (4) years of Clinical Quality Assurance experience.
• Knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines and their application.
• A minimum of two (2) years of management responsibility, preferably associates in clinical research.
• Good management skills, with the ability to assign and monitor work.
• Strong verbal and written communication skills.
• Proficient MS office skills (e.g., Word, Excel, Power Point, Visio, Outlook, Teams, Project, etc.).

Desired Qualifications

• Medical device industry experience.
• Experience in compliance program.
• Experience in designing, monitoring, and implementing clinical trials and interpreting trial results, including understanding of biostatistics and safety reporting.
• A minimum of four (4) years of Clinical research experience.
• Able to handle multiple tasks efficiently and consistently and meet deadlines.
• Detail-oriented.
• Ability to maintain strict confidentiality.

Posting Country: US – United States

Please click here to apply.