🏥 We're Hiring: Clinical Compliance Manager
📍 Location: United Arab Emirates (Remote)
🕒 Employment Type: Full-Time
💼 Experience Level: Mid-Level to Senior
🌐 Work Arrangement: Fully Remote
About Us
We are a healthcare and life-sciences-focused organization committed to maintaining the highest standards of clinical quality, patient safety, regulatory compliance, data integrity, and ethical clinical research.
Our distributed teams collaborate across Clinical Operations, Medical Affairs, Regulatory Affairs, Quality Assurance, Pharmacovigilance, Data Management, Biostatistics, Legal, Compliance, Research Sites, Investigators, Contract Research Organizations, and Executive Leadership to ensure clinical activities are conducted safely, ethically, and in accordance with applicable regulations and standards.
The Role
We are seeking an experienced Clinical Compliance Manager to lead clinical compliance programs, GCP oversight, audit readiness, quality management, regulatory requirements, inspection preparedness, clinical documentation, and risk-based compliance activities across clinical research programs.
The ideal candidate will combine strong knowledge of clinical research regulations and Good Clinical Practice with quality-management expertise, audit capabilities, risk assessment, stakeholder management, and practical knowledge of clinical trial operations.
The role will be responsible for establishing and maintaining clinical compliance frameworks, monitoring trial conduct, identifying compliance risks, coordinating audits and inspections, managing corrective actions, and supporting continuous improvement across the clinical development lifecycle.
Key Responsibilities
- Develop and implement clinical compliance strategies, policies, procedures, standards, and governance frameworks aligned with applicable regulations and organizational objectives.
- Establish risk-based clinical compliance programs covering clinical trials, research activities, investigators, sites, vendors, and clinical documentation.
- Ensure clinical activities are conducted in accordance with applicable laws, regulations, Good Clinical Practice (GCP), ethical principles, approved protocols, and internal procedures.
- Monitor developments in applicable clinical research regulations, regulatory guidance, ethical standards, and industry expectations.
- Conduct clinical compliance assessments, quality reviews, audits, and risk-based monitoring activities.
- Evaluate clinical trial processes, systems, documentation, and controls to identify potential compliance gaps.
- Develop and maintain clinical compliance risk assessments and risk registers.
- Identify critical and major compliance risks and develop appropriate mitigation strategies.
- Coordinate internal audits, vendor audits, investigator-site audits, quality assessments, and other compliance reviews.
- Support regulatory authority inspections and ensure clinical teams and documentation are prepared for inspection.
- Develop inspection-readiness programs, mock inspections, readiness assessments, and remediation plans.
- Manage audit findings, inspection observations, deviations, CAPAs, preventive actions, and compliance commitments through to closure.
- Review clinical trial documentation to assess completeness, accuracy, consistency, traceability, and compliance.
- Monitor the quality and completeness of essential clinical trial documents and Trial Master File (TMF) records.
- Assess compliance with clinical protocols, informed-consent requirements, investigator responsibilities, safety-reporting obligations, and other trial requirements.
- Collaborate with Clinical Operations to identify and resolve protocol deviations, site compliance issues, documentation deficiencies, and operational risks.
- Work closely with Pharmacovigilance teams to ensure appropriate safety reporting, adverse-event management, and regulatory compliance.
- Coordinate with Regulatory Affairs on clinical-trial applications, regulatory submissions, authority communications, inspection requirements, and other regulatory matters.
- Support the development and maintenance of Quality Management Systems (QMS) applicable to clinical research.
- Establish clinical quality metrics, risk indicators, dashboards, and performance-monitoring frameworks.
- Analyze clinical compliance trends and identify systemic issues, recurring deviations, and opportunities for process improvement.
- Develop and maintain clinical compliance SOPs, work instructions, guidelines, templates, checklists, and training materials.
- Ensure clinical teams and relevant stakeholders receive appropriate compliance training.
- Develop and deliver training on GCP, clinical compliance, inspection readiness, documentation standards, protocol compliance, and quality requirements.
- Evaluate the compliance performance of Clinical Research Organizations (CROs), vendors, laboratories, technology providers, and other external partners.
- Support vendor qualification, due diligence, quality agreements, performance assessments, and compliance monitoring.
- Review clinical contracts and operational agreements from a compliance and quality perspective in collaboration with Legal and Procurement teams.
- Monitor clinical systems and technology platforms for compliance with applicable requirements relating to data integrity, security, access, audit trails, and electronic records.
- Support validation and compliance activities for computerized systems used in clinical research where applicable.
- Ensure clinical data and documentation maintain appropriate levels of integrity, accuracy, confidentiality, and traceability.
- Investigate significant compliance issues, deviations, suspected misconduct, data-integrity concerns, and other clinical-quality events.
- Conduct root-cause analysis and develop effective corrective and preventive measures.
- Maintain comprehensive compliance records, audit reports, CAPA registers, inspection records, training records, deviation logs, risk assessments, and quality documentation.
- Establish and monitor clinical compliance KPIs and provide regular reporting to senior management.
- Prepare inspection-readiness reports, quality reviews, compliance assessments, executive presentations, risk reports, and strategic recommendations.
Key Performance Indicators (KPIs)
Performance will be measured through a combination of clinical quality, compliance, regulatory, operational, and risk-management KPIs, including:
- GCP compliance rate
- Clinical audit performance
- Regulatory inspection readiness
- Inspection findings
- Critical and major findings
- CAPA closure rate
- CAPA effectiveness
- Protocol deviation trends
- Essential-document completeness
- TMF quality and completeness
- Training compliance
- Vendor compliance
- Site compliance performance
- Clinical quality-risk indicators
- Audit finding recurrence
- Compliance issue resolution time
- Data-integrity performance
- Regulatory submission compliance
- Inspection-readiness performance
- Clinical quality improvement initiatives
Candidate Profile
The successful candidate should have strong experience in clinical compliance, clinical quality assurance, clinical operations, regulatory affairs, GCP, or a related life-sciences discipline.
Experience within pharmaceutical, biotechnology, medical-device, diagnostics, CRO, healthcare, or clinical research organizations would be advantageous.
The candidate should have practical experience supporting clinical trials and a strong understanding of regulatory expectations, GCP principles, quality-management systems, audits, inspections, CAPA, and risk-based compliance.
What You'll Bring
- Proven experience in clinical compliance, clinical quality, clinical operations, GCP, or a related role.
- Strong knowledge of ICH-GCP principles and applicable clinical research regulations.
- Experience developing and implementing clinical quality and compliance programs.
- Experience conducting or managing clinical audits and compliance assessments.
- Strong understanding of regulatory inspection processes and inspection readiness.
- Experience managing CAPAs, deviations, audit findings, and compliance remediation.
- Strong knowledge of clinical trial documentation and TMF requirements.
- Experience assessing investigator sites, CROs, vendors, and clinical partners.
- Understanding of clinical data integrity and computerized-system compliance.
- Strong knowledge of informed consent, protocol compliance, safety reporting, and investigator responsibilities.
- Excellent analytical, documentation, communication, and stakeholder-management skills.
- Strong risk-assessment and root-cause-analysis capabilities.
- Ability to interpret complex regulatory requirements and translate them into practical clinical processes.
- Experience developing SOPs, training programs, quality metrics, and compliance dashboards.
- Strong attention to detail and ability to manage sensitive clinical and patient-related information appropriately.
- Highly ethical, analytical, detail-oriented, and quality-focused.
- Ability to manage multiple clinical programs, audits, risks, and regulatory requirements simultaneously.
- Ability to work independently and effectively within a fully remote environment.
- Relevant degree in Life Sciences, Pharmacy, Medicine, Nursing, Biomedical Sciences, or a related discipline is advantageous.
- Professional certification such as CQA, RAC, or relevant GCP/clinical-quality certification is advantageous.
- Experience working within the UAE, GCC, or wider Middle East healthcare and clinical-research environment is advantageous.