أبلاي إيدج ابدأ البحث عن عمل

Clinical Trial Manager

Nextgen For Recruitment & Consulting Services · United Arab Emirates

قدّم وتابع مع أبلاي إيدج
🌟 We're Hiring: Clinical Trial Manager📍 Location: United Arab Emirates (Remote)🕒 Employment Type: Full-Time💼 Experience Level: Mid-Level to SeniorAbout UsWe 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 to deliver safe, compliant, and impactful clinical trial programs that improve patient outcomes.The RoleWe are seeking an experienced Clinical Trial Manager to lead the planning, execution, and oversight of clinical research studies from initiation through closeout. The ideal candidate will manage cross-functional clinical trial activities, ensure compliance with regulatory requirements and Good Clinical Practice (GCP) standards, and drive successful study delivery within scope, timeline, budget, and quality expectations.Key ResponsibilitiesDevelop 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 Clinical Research Associates (CRAs), Investigators, Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, Quality Assurance, Contract Research Organizations (CROs), and Executive Leadership to ensure successful trial execution.Manage clinical trial timelines, budgets, resources, risks, vendors, and operational milestones to achieve study objectives.Oversee clinical trial sites, investigator relationships, monitoring activities, protocol adherence, and resolution of study-related issues.Ensure compliance with International Council for Harmonisation Good Clinical Practice (ICH-GCP), regulatory authority requirements, ethics committee approvals, clinical protocols, and organizational procedures.Monitor key performance indicators (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 corrective and preventive action (CAPA) planning to maintain clinical trial integrity.Manage relationships with CROs, clinical investigators, research institutions, laboratories, vendors, and regulatory stakeholders.Support regulatory submissions, inspection readiness activities, essential document management, trial master file (TMF) oversight, and audit preparation.Drive clinical research transformation through electronic Trial Master Files (eTMF), Clinical Trial Management Systems (CTMS), electronic data capture (EDC), artificial intelligence (AI)-powered analytics, and automated workflows.Utilize CTMS platforms, EDC systems, eTMF solutions, regulatory tracking tools, Microsoft Office Suite, Power BI, and clinical analytics platforms to monitor study performance and generate actionable insights.Prepare clinical trial reports, study dashboards, risk assessments, executive presentations, and strategic recommendations for senior leadership.Lead, mentor, and develop clinical research associates, study coordinators, project specialists, and cross-functional teams while fostering a culture of scientific excellence, compliance, collaboration, and continuous improvement.RequirementsBachelor'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 Certified Clinical Research Professional (CCRP), Project Management Professional (PMP), Clinical Research Associate (CRA) certification, or equivalent 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 Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), electronic Trial Master File (eTMF), regulatory information management systems, Microsoft Office Suite, Power BI, and clinical research software.Familiarity with adaptive trial designs, decentralized clinical trials (DCTs), real-world evidence (RWE), 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, with flexibility to support clinical sites, investigator meetings, audits, and regulatory activities as required.What We OfferFlexible 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.