Full-time
FoodTechSafety Jobs
A Pharmaceutical Research Industry in Dubai, UAE i looking for a Clinical Trial Coordinator. This role will support regional clinical research operations and work closely with Clinical Trial Managers, Site Quality & Compliance teams, investigators, sponsors, and external vendors throughout the clinical trial lifecycle.
The successful candidate will play a critical role in ensuring that clinical studies are conducted efficiently, ethically, and in compliance with international regulatory requirements, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and company quality standards. This position offers an excellent opportunity for professionals looking to advance their careers in clinical research, pharmaceutical development, drug safety, and trial management.
Job Responsibilities
Clinical Trial Administration & Coordination
- Provide comprehensive administrative and operational support to Clinical Trial Managers across regional clinical studies.
- Coordinate clinical trial activities throughout the study lifecycle, including study start-up, maintenance, monitoring, and close-out phases.
- Ensure all trial-related activities are completed according to project timelines, study protocols, regulatory requirements, and internal procedures.
- Collaborate with cross-functional clinical research teams to facilitate smooth trial execution.
Trial Master File (TMF) Management
- Lead Trial Master File (TMF) management activities and ensure complete, accurate, and inspection-ready documentation.
- Maintain trial documentation in accordance with ICH-GCP guidelines and company quality standards.
- Track document collection, filing, version control, and archiving processes.
- Ensure essential documents are properly maintained and available for audits, inspections, and regulatory submissions.
Document Control & Compliance
- Manage clinical trial documentation and support document lifecycle processes.
- Review, organize, and maintain study-related records in electronic document management systems.
- Ensure documentation complies with regulatory authority requirements and organizational standards.
- Support quality assurance initiatives through effective document management practices.
Clinical Trial Management System (CTMS) Administration
- Maintain and update Clinical Trial Management Systems (CTMS) with accurate and timely study information.
- Monitor study milestones, site activities, and trial progress within designated systems.
- Generate reports and support data accuracy for clinical project management activities.
- Assist in tracking study performance metrics and operational deliverables.
Vendor & System Management
- Coordinate vendor onboarding and setup activities for clinical trial operations.
- Manage system access requests, user account creation, permissions, and training coordination.
- Support vendor communications and documentation requirements.
- Process account requests, reporting requests, and operational system-related activities.
Meeting Coordination & Communication
- Organize and coordinate regional trial-level meetings and project discussions.
- Prepare, document, and distribute meeting agendas and minutes.
- Track action items and follow-up activities to ensure timely completion.
- Facilitate effective communication between study teams, vendors, and stakeholders.
Audit, Inspection & Quality Support
- Support internal audits, sponsor audits, regulatory inspections, and quality reviews.
- Assist in preparing trial documentation and evidence required during inspections.
- Contribute to Corrective and Preventive Action (CAPA) management activities.
- Ensure compliance with applicable regulatory standards, SOPs, and quality management systems.
Cross-Functional Collaboration
- Work closely with Clinical Operations, Quality Assurance, Regulatory Affairs, Data Management, and external stakeholders.
- Support continuous process improvement initiatives within clinical research operations.
- Promote a culture of quality, compliance, and operational excellence.
Job Qualifications
- Bachelor’s Degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Sciences, Clinical Research, Pharmaceutical Sciences, or a related field.
- Master’s Degree in Life Sciences, Clinical Research, Public Health, or a related discipline is an advantage.
- Minimum 1 year of experience in Clinical Trial Administration, Clinical Operations, Clinical Research Coordination, Pharmaceutical Research, or Contract Research Organizations (CROs).
- Experience supporting multicenter clinical trials and regulatory documentation processes is preferred.
- Familiarity with global clinical research regulations and compliance requirements.
- Strong knowledge of Trial Master File (TMF) management processes.
- Experience with Clinical Trial Management Systems (CTMS).
- Excellent knowledge and hands-on experience with Veeva Systems, including document management platforms.
- Understanding of ICH-GCP guidelines, clinical trial regulations, and quality management principles.
- Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook.
Language Requirements
- Fluent English communication skills, both written and verbal.
- Strong organizational and multitasking abilities.
- Excellent attention to detail and documentation accuracy.
- Ability to work independently and within cross-functional teams.
- Effective stakeholder management and communication skills.
- Ability to manage multiple priorities in a fast-paced clinical research environment.
- Strong problem-solving and analytical capabilities.
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