linkedin
Clinical Trial Manager
Nextgen For Recruitment & Consulting Services
Abu Dhabi, UAE
Full Time
Senior
Hybrid
Today
Clinical Trial ManagementICH GCPRegulatory ComplianceCTMSEDCeTMF
Free
Job Fit Check
Base Career helps you apply smarter for this job.
?%
Ready to ScanKey skills for this role
Clinical Trial ManagementICH GCPRegulatory Compliance
About the Role
We are hiring an experienced Clinical Trial Manager to lead the planning, execution, and oversight of clinical research studies from initiation through closeout. The role requires managing cross-functional activities, ensuring compliance with ICH-GCP and regulatory requirements, and driving successful study delivery.
Key Skills for This Role
Clinical Trial ManagementICH GCPRegulatory ComplianceCTMSEDCeTMF
Responsibilities
- Develop and implement clinical trial strategies, study management plans, operational frameworks, and execution roadmaps aligned with research objectives and regulatory requirements
- Lead end to end clinical trial management activities including study startup, site selection, site activation, patient recruitment, monitoring oversight, data review, study closeout, and final reporting
- Collaborate with CRAs, Investigators, Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, Quality Assurance, CROs, and Executive Leadership
- Manage clinical trial timelines, budgets, resources, risks, vendors, and operational milestones
- Oversee clinical trial sites, investigator relationships, monitoring activities, protocol adherence, and resolution of study related issues
- Ensure compliance with ICH GCP, regulatory authority requirements, ethics committee approvals, clinical protocols, and organizational procedures
- Monitor KPIs including patient recruitment rates, site performance, study timelines, protocol deviations, data quality, monitoring compliance, regulatory milestones, and trial costs
- Conduct risk assessments, issue management, quality reviews, and CAPA planning
- Manage relationships with CROs, clinical investigators, research institutions, laboratories, vendors, and regulatory stakeholders
- Support regulatory submissions, inspection readiness activities, essential document management, TMF oversight, and audit preparation
- Drive clinical research transformation through eTMF, CTMS, EDC, AI powered analytics, and automated workflows
- Lead, mentor, and develop clinical research associates, study coordinators, project specialists, and cross functional teams
Requirements
- Bachelor's degree in Life Sciences, Clinical Research, Pharmacy, Medicine, Nursing, Biomedical Sciences, Biotechnology, Healthcare Administration, or related field
- Minimum 5 years of experience in clinical research, clinical trial management, pharmaceutical development, biotechnology, medical research, or related roles
- At least 2 years of experience managing clinical trials, research projects, CRO relationships, or multidisciplinary clinical teams
- Strong understanding of clinical trial processes, ICH GCP guidelines, regulatory submissions, ethics committee requirements, clinical operations, pharmacovigilance, and quality management systems
- Experience with CTMS, EDC, eTMF, regulatory information management systems, Microsoft Office Suite, Power BI, and clinical research software
- Master's degree or professional certifications such as CCRP, PMP, CRA certification are highly advantageous
- Familiarity with adaptive trial designs, decentralized clinical trials, real world evidence, digital health technologies, AI powered clinical analytics, and global regulatory environments is advantageous
Full Job Posting
About Us
- We are a research driven healthcare organization committed to advancing medical innovation through high quality clinical research and evidence based solutions.
- Our teams collaborate across Clinical Research, Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, Quality Assurance, Pharmacovigilance, Healthcare Providers, and Executive Leadership.
Key Responsibilities
- Develop and implement clinical trial strategies, study management plans, operational frameworks, and execution roadmaps.
- Lead end to end clinical trial management activities including study startup, site selection, site activation, patient recruitment, monitoring oversight, data review, study closeout, and final reporting.
- Collaborate with CRAs, Investigators, Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, Quality Assurance, CROs, and Executive Leadership.
- Manage clinical trial timelines, budgets, resources, risks, vendors, and operational milestones.
- Oversee clinical trial sites, investigator relationships, monitoring activities, protocol adherence, and resolution of study related issues.
- Ensure compliance with ICH GCP, regulatory authority requirements, ethics committee approvals, clinical protocols, and organizational procedures.
- Monitor KPIs including patient recruitment rates, site performance, study timelines, protocol deviations, data quality, monitoring compliance, regulatory milestones, and trial costs.
- Conduct risk assessments, issue management, quality reviews, and CAPA planning.
- Manage relationships with CROs, clinical investigators, research institutions, laboratories, vendors, and regulatory stakeholders.
- Support regulatory submissions, inspection readiness activities, essential document management, TMF oversight, and audit preparation.
- Drive clinical research transformation through eTMF, CTMS, EDC, AI powered analytics, and automated workflows.
- Lead, mentor, and develop clinical research associates, study coordinators, project specialists, and cross functional teams.
Requirements
- Bachelor's degree in Life Sciences, Clinical Research, Pharmacy, Medicine, Nursing, Biomedical Sciences, Biotechnology, Healthcare Administration, or a related field.
- Master's degree or professional certifications such as CCRP, PMP, CRA certification are highly advantageous.
- Minimum 5 years of experience in clinical research, clinical trial management, pharmaceutical development, biotechnology, medical research, or related roles.
- At least 2 years of experience managing clinical trials, research projects, CRO relationships, or multidisciplinary clinical teams preferred.
- Strong understanding of clinical trial processes, ICH GCP guidelines, regulatory submissions, ethics committee requirements, clinical operations, pharmacovigilance, and quality management systems.
- Experience with CTMS, EDC, eTMF, regulatory information management systems, Microsoft Office Suite, Power BI, and clinical research software.
- Familiarity with adaptive trial designs, decentralized clinical trials, real world evidence, digital health technologies, AI powered clinical analytics, and global regulatory environments is advantageous.
- Strong leadership, analytical, communication, stakeholder management, organizational, risk management, and problem solving skills.
- Ability to manage complex clinical studies while balancing patient safety, scientific integrity, regulatory compliance, timelines, budgets, and business objectives.
- Ability to work independently and effectively in remote and hybrid environments.
What We Offer
- Flexible remote/hybrid work opportunity within the United Arab Emirates.
- Competitive compensation package.
- Professional development and clinical research leadership growth opportunities.
- Exposure to innovative therapies, global clinical research programs, digital health technologies, and advanced trial management practices.
- Collaborative culture focused on scientific excellence, patient safety, integrity, and continuous improvement.
- Opportunity to lead impactful clinical trials that advance healthcare innovation and improve patient outcomes.
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career