Clinical Research Manager
EXP CONTROLE BIOLÓGICO · United Arab Emirates
Apply & track with Apply Edge🌟 We're Hiring: Clinical Research Manager📍 Location: United Arab Emirates (Remote)🕒 Employment Type: Full-Time💼 Experience Level: Mid-Level to Senior🌐 Work Arrangement: Fully RemoteAbout UsWe are a research-driven healthcare organization dedicated to advancing medical innovation through ethical, high-quality clinical research. Our distributed teams collaborate across Clinical Research, Medical Affairs, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, Clinical Operations, Quality Assurance, Laboratory Services, Information Technology, and Executive Leadership to deliver impactful research that improves patient outcomes and accelerates scientific discovery.The RoleWe are seeking an experienced Clinical Research Manager to lead clinical research programmes, study operations, regulatory compliance, and cross-functional research initiatives. The ideal candidate will oversee clinical trial planning, site management, study execution, data integrity, quality assurance, and multidisciplinary collaboration while ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), and ethical standards.Key ResponsibilitiesDevelop and implement clinical research strategies, study management frameworks, and operational plans aligned with organizational objectives and research priorities.Lead Phase I–IV clinical trials, observational studies, investigator-sponsored research, and post-market clinical studies from study start-up through closeout.Collaborate with Medical Affairs, Regulatory Affairs, Biostatistics, Clinical Operations, Pharmacovigilance, Data Management, Laboratory Services, Quality Assurance, Ethics Committees, Principal Investigators, and Executive Leadership to ensure successful study execution.Develop study timelines, budgets, resource plans, recruitment strategies, monitoring plans, and risk management frameworks.Oversee clinical site selection, feasibility assessments, site initiation, monitoring activities, vendor management, and investigator relationships.Ensure participant safety through protocol compliance, informed consent oversight, adverse event reporting, safety monitoring, and data integrity management.Coordinate clinical trial documentation, regulatory submissions, Institutional Review Board (IRB) and Ethics Committee communications, trial master file (TMF) maintenance, and essential document management.Monitor study progress, enrollment performance, protocol deviations, data quality, regulatory compliance, and study milestones.Ensure compliance with UAE healthcare regulations, International Council for Harmonisation Good Clinical Practice (ICH-GCP), Declaration of Helsinki, applicable FDA and EMA guidelines where relevant, data privacy regulations, and organizational policies.Monitor key performance indicators (KPIs) including participant recruitment, retention rates, protocol compliance, data query resolution, study milestone achievement, audit outcomes, regulatory inspection readiness, budget performance, and study quality.Conduct quality reviews, risk assessments, study audits, vendor evaluations, inspection readiness activities, and continuous improvement initiatives.Manage clinical research budgets, contract research organizations (CROs), research vendors, laboratory partners, technology platforms, and strategic research initiatives.Drive digital transformation through artificial intelligence (AI)-powered patient recruitment, predictive enrollment analytics, risk-based monitoring, electronic informed consent (eConsent), decentralized clinical trial technologies, workflow automation, and business intelligence solutions.Utilize Medidata Rave, Veeva Vault, Oracle Clinical, REDCap, IBM Clinical Development, Trial Master File (TMF) platforms, Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), Microsoft 365, Power BI, Tableau, and research analytics platforms to optimize study performance and generate actionable insights.Prepare executive dashboards, study status reports, regulatory updates, safety summaries, enrollment analyses, audit reports, and strategic recommendations for senior leadership and research sponsors.Lead, mentor, and develop clinical research associates, clinical trial coordinators, data managers, research nurses, regulatory specialists, and multidisciplinary research teams while fostering a culture of scientific excellence, ethics, collaboration, accountability, and continuous improvement.RequirementsBachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, Biomedical Sciences, Clinical Research, Public Health, or a related field.Master's degree in Clinical Research, Public Health (MPH), Biomedical Sciences, Healthcare Administration, Business Administration (MBA), or a related discipline is highly advantageous.Professional certifications such as Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Project Management Professional (PMP), Association of Clinical Research Professionals (ACRP) certification, or equivalent are preferred.Minimum 5 years of experience in clinical research, clinical trial management, clinical operations, medical research, or related roles.At least 2 years of experience managing clinical studies, research programmes, clinical trial teams, CRO partnerships, or multidisciplinary research initiatives preferred.Strong understanding of ICH-GCP guidelines, clinical trial regulations, research ethics, study design, protocol development, regulatory submissions, pharmacovigilance, clinical data management, and quality assurance.Experience with Medidata Rave, Veeva Vault, Oracle Clinical, REDCap, IBM Clinical Development, EDC systems, CTMS platforms, Microsoft Office Suite, Power BI, Tableau, and clinical research software.Familiarity with AI-powered clinical trial technologies, decentralized clinical trials (DCTs), predictive patient recruitment, digital health technologies, remote monitoring, and advanced clinical analytics is highly advantageous.Strong leadership, communication, stakeholder management, analytical thinking, project management, budgeting, organizational, and problem-solving skills.Ability to manage multiple clinical research initiatives while balancing participant safety, scientific quality, regulatory compliance, budgets, timelines, and stakeholder expectations.Ability to work effectively in a remote environment with distributed research teams, investigators, healthcare providers, sponsors, CROs, regulators, ethics committees, and global stakeholders, with occasional travel for site visits, investigator meetings, audits, regulatory inspections, and scientific conferences as required.What We OfferFully remote work arrangement with flexible collaboration across global clinical research and medical teams.Competitive compensation package with performance-based incentives.Comprehensive health and wellness benefits.Professional development and clinical research leadership growth opportunities.Exposure to AI-powered clinical trial technologies, decentralized research platforms, advanced data analytics, digital health innovations, and next-generation medical research solutions.Collaborative culture focused on scientific excellence, patient safety, ethics, innovation, and continuous improvement.Opportunity to contribute to groundbreaking medical research by leading clinical studies that advance healthcare, improve patient outcomes, and shape the future of medicine.