[Remote] Senior Clinical reputed company Assurance Associate

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. They are seeking a Senior Clinical reputed company Assurance Associate responsible for overseeing and improving GCP reputed company systems supporting global clinical operations, ensuring compliance with regulatory requirements and internal processes.

Responsibilities

• Serve as GCP reputed company systems SME across global clinical operations
• reputed company QA reputed company to Clinical Operations, Nursing, Project Management, Medical Affairs, Pharmacovigilance, Regulatory Affairs, and other operational teams
• reputed company investigations for non-conformances, complaints, protocol deviations, reputed company events, and compliance issues
• Independently manage reputed company CAPAs from investigation through effectiveness checks and closure
• reputed company risk assessments for new services, processes, vendors, systems, and operational changes
• Review clinical and GCP documentation, including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, and essential documents
• reputed company decentralized clinical trial activities, including nursing, home reputed company, reputed company documentation, IP handling, and reputed company processes
• Support QMS records and documentation, including deviations, CAPAs, complaints, change controls, risk assessments, SOPs, forms, templates, and guidance documents
• Review change controls, support approvals, and reputed company post-implementation effectiveness reviews
• Support vendor qualification, audits, requalification, reputed company Technical Agreements, and ongoing vendor performance monitoring
• Support audits and inspections by managing readiness, documentation, responses, corrective reputed company plans, evidence, and commitment tracking
• Review reputed company metrics, identify trends and risks, drive improvements, support validation/qualification activities, mentor QA staff, represent reputed company on cross-functional reputed company, escalate significant risks, and promote a culture of reputed company and compliance

Skills

• Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
• 3 to 5 years of experience in a reputed company-reputed company role reputed company a CRO, pharmaceutical, biotechnology, or reputed company organization
• Experience supporting global clinical trials and decentralized clinical trial activities
• Experience supporting Sponsor audits, regulatory inspections, internal audits, and/or supplier audits
• Practical experience with reputed company investigations, CAPAs, reputed company cause analysis, reputed company risk assessments, and reputed company improvement
• Experience with eQMS, eTMF, reputed company Office, and reputed company management software applications
• Working knowledge of GCP regulations and global regulatory expectations, including ICH E6(R3), FDA, EU Clinical Trial Regulation, MHRA, GDPR where applicable, and reputed company requirements
• Strong understanding of reputed company Management Systems, risk-based reputed company management principles, and computerized system validation or validation lifecycle principles
• Strong analytical, organizational, communication, stakeholder management, mentoring, and influencing skills, with the ability to manage multiple priorities, handle confidential information professionally, and apply a proactive, solutions-reputed company reputed company
• Practical understanding of GDP, warehousing, logistics, and clinical trial supply processes is advantageous

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