أبلاي إيدج ابدأ البحث عن عمل

Clinical Compliance Manager

Arab Coordination Group (ACG) · United Arab Emirates

قدّم وتابع مع أبلاي إيدج
We're Hiring: Clinical Compliance ManagerLocation: United Arab Emirates (Remote)Employment Type: Full-TimeExperience Level: Mid-Level to SeniorWork Arrangement: Fully RemoteAbout UsWe are a globally focused organization committed to maintaining high standards of clinical quality, regulatory compliance, patient safety, ethical conduct, and operational integrity across healthcare and clinical environments.Our teams collaborate across Clinical Operations, Medical Affairs, Quality, Regulatory, Legal, Data, Research, Safety, and external partners to ensure clinical activities are conducted consistently, ethically, and in accordance with applicable requirements.The RoleWe are seeking an experienced Clinical Compliance Manager to lead clinical compliance programs, regulatory readiness, quality oversight, audit activities, risk management, documentation standards, and corrective-action initiatives.The ideal candidate will provide strategic and operational guidance to ensure clinical activities, processes, documentation, and systems meet applicable regulations, ethical standards, quality requirements, and organizational policies.Key ResponsibilitiesDevelop and implement clinical compliance strategies, policies, procedures, and governance frameworks.Establish risk-based compliance programs covering clinical operations and related activities.Monitor compliance with applicable clinical, healthcare, research, privacy, quality, and regulatory requirements.Support compliance with Good Clinical Practice (GCP) and applicable clinical research standards.Conduct clinical compliance assessments, process reviews, audits, and monitoring activities.Develop annual compliance plans based on clinical, operational, regulatory, and patient-safety risks.Identify compliance gaps, control weaknesses, process deviations, and emerging clinical risks.Review clinical documentation, records, processes, systems, and operational practices for compliance.Coordinate internal, external, sponsor, regulatory, and quality audits.Prepare clinical teams and facilities for inspections and regulatory assessments.Support inspection readiness through documentation reviews, mock inspections, training, and remediation.Review audit and inspection findings and evaluate root causes and potential impact.Develop corrective and preventive action plans with responsible stakeholders.Monitor remediation activities and ensure actions are completed within agreed timelines.Escalate significant or recurring compliance issues to appropriate leadership.Maintain clinical compliance, audit, issue, CAPA, and risk registers.Review and update clinical policies, standard operating procedures, work instructions, and compliance guidance.Ensure clinical procedures are appropriately documented, controlled, communicated, and implemented.Partner with Clinical Operations to strengthen compliance throughout the clinical lifecycle.Collaborate with Quality, Regulatory Affairs, Medical Affairs, Legal, Data Management, Pharmacovigilance, and other relevant functions.Provide compliance guidance for clinical programs, studies, trials, sites, and operational initiatives.Support evaluation and qualification of clinical sites, investigators, vendors, and service providers.Monitor third-party clinical partners for compliance with contractual and regulatory requirements.Review vendor oversight processes and identify potential compliance risks.Support clinical training programs covering compliance requirements, procedures, documentation, and quality standards.Monitor training completion and assess whether employees understand relevant compliance obligations.Review deviations, protocol-related issues, non-conformities, complaints, and other clinical compliance events.Support investigations and root-cause analyses involving significant compliance issues.Evaluate trends in deviations, findings, complaints, and CAPAs to identify systemic risks.Ensure appropriate documentation and escalation of significant clinical compliance matters.Support patient-safety and risk-management activities where clinical compliance issues may affect safety.Collaborate with Privacy and Data teams regarding clinical data protection, confidentiality, and information-handling requirements.Monitor changes in applicable clinical and regulatory requirements and assess operational impact.Translate regulatory requirements into practical procedures and control measures.Maintain inspection-ready documentation and evidence across relevant clinical functions.Develop compliance dashboards and management reports covering risks, findings, CAPAs, training, and audit performance.Establish and monitor clinical compliance KPIs and risk indicators.Identify opportunities to improve compliance processes through technology, automation, analytics, and workflow optimization.Conduct periodic compliance reviews to evaluate program effectiveness and control maturity.Benchmark clinical compliance practices against recognized industry standards.Promote a culture of quality, ethical conduct, accountability, patient safety, and continuous improvement.Provide senior leadership with recommendations regarding compliance risks, regulatory developments, and improvement priorities.Key Performance IndicatorsClinical compliance rateAudit and inspection readinessAudit finding closure rateHigh-risk finding remediation timeCAPA closure performanceRepeat finding rateProtocol deviation trendsCompliance assessment completionSOP complianceTraining completion rateClinical documentation accuracyDocumentation completenessRegulatory submission or response timelinessSite and vendor complianceInspection finding frequencyCompliance incident frequencyRisk assessment completionIssue escalation timelinessCorrective-action effectivenessClinical quality performancePatient-safety compliance indicatorsData and privacy complianceReporting accuracyCompliance monitoring coverageOverall compliance maturityIdeal CandidateThe successful candidate should have strong experience in clinical compliance, clinical operations, clinical research, healthcare quality, regulatory affairs, GCP, or related regulated environments.The candidate should demonstrate:Strong knowledge of clinical compliance principles and Good Clinical Practice.Experience managing clinical compliance programs, audits, inspections, or quality systems.Understanding of applicable clinical research, healthcare, patient-safety, and regulatory requirements.Experience conducting risk assessments, compliance reviews, and internal audits.Strong understanding of CAPA, root-cause analysis, deviations, non-conformities, and issue management.Experience supporting regulatory inspections and inspection-readiness programs.Ability to interpret regulatory requirements and translate them into operational controls.Experience managing clinical sites, vendors, investigators, or external service providers.Strong documentation, analytical, and problem-solving skills.Excellent attention to detail and ability to identify systemic compliance risks.Strong project-management and organizational capabilities.Excellent written and verbal English communication skills.Ability to communicate effectively with clinical, technical, regulatory, and senior-management stakeholders.Strong ethical judgment, confidentiality, independence, and professional integrity.Experience working with international and distributed teams.Familiarity with clinical quality systems, electronic documentation platforms, compliance databases, and audit-management tools.Relevant professional qualifications in clinical research, healthcare quality, regulatory affairs, compliance, or a related discipline are advantageous.