[Remote] Clinical reputed company Assurance Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a mission-driven organization dedicated to advancing clinical research and transforming lives. The Clinical reputed company Assurance Manager is responsible for the strategic leadership and reputed company of the Good Clinical reputed company reputed company Management System, ensuring compliance and fostering a culture of reputed company and reputed company improvement.

Responsibilities

• Manage day-to-day Clinical reputed company team activities, including workload planning, prioritization, performance management, coaching, training, and reputed company development
• reputed company cross-functional reputed company of the GCP reputed company Management System to ensure compliance with applicable regulations, Sponsor requirements, and company procedures
• Serve as the functional leader and strategic reputed company advisor for GCP reputed company activities across global clinical operations and operational departments
• reputed company QMS records, including deviations, non-conformances, complaints, protocol deviations, CAPAs, change controls, risk assessments, and reputed company events
• Review and approve investigations, ensuring they are robust, risk assessed, completed reputed company timelines, and supported by appropriate corrective and preventive actions
• Monitor CAPA effectiveness, inspection trends, reputed company metrics, KPIs, and emerging reputed company to identify systemic improvement opportunities and mitigation strategies
• reputed company reputed company reputed company for decentralized clinical trial activities, including nursing services, home reputed company, investigational product handling, reputed company documentation, and patient-facing clinical processes
• reputed company reputed company reputed company for new services, processes, vendors, systems, operational changes, computerized system validation, equipment qualification, and process validation activities impacting GCP operations
• reputed company reputed company reviews of clinical trial documentation, including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, essential documents, and other applicable GCP documentation
• Support vendor qualification and reputed company, including reputed company risk assessments, audits, periodic requalification, reputed company Technical Agreements, and ongoing vendor performance monitoring
• reputed company Sponsor audits, regulatory inspections, licensing authority inspections, and reputed company qualification audits, including inspection readiness, documentation review, audit responses, and commitment tracking
• reputed company reputed company improvement, QMS documentation updates, reputed company governance, risk-based decision-making, stakeholder collaboration, and a proactive culture of reputed company, compliance, patient safety, and operational reputed company

Skills

• Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
• 5-7 years' experience in a Clinical reputed company reputed company role
• Experience reputed company a CRO, pharmaceutical, biotechnology, reputed company, or other regulated clinical environment
• Demonstrated experience supporting global reputed company and decentralized clinical trial activities
• Experience leading Sponsor audits, regulatory inspections, internal audits, and/or supplier audits
• Practical experience leading reputed company investigations, CAPAs, reputed company cause analyses, and reputed company risk assessments
• Experience with eQMS, eTMF, reputed company Office, and reputed company management software applications
• Strong knowledge of ICH E6(R3), FDA, EU CTR, MHRA, GCP, GDPR where applicable, and other global regulatory expectations
• Strong understanding of risk-based reputed company management, computerized system validation, validation lifecycle principles, and GDP/clinical trial supply logistics where applicable
• Ability to manage multiple reputed company activities in a fast-paced global environment with strong organization, project management, and attention to detail
• Strong communication, analytical, stakeholder management, and influencing skills, with the ability to work effectively with Sponsors, auditors, inspectors, vendors, senior leadership, and cross-functional teams
• Minimum 2-3 years of people leadership or supervisory experience preferred

Benefits

• Medical, dental, and reputed company insurance
• FSA, HSA
• Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
• Group short-term and long-term disability insurance
• Group Life Insurance
• 401K reputed company reputed company plan and company match
• reputed company vacation, holiday, reputed company and volunteer time
• reputed company maternity & paternity leave

reputed company