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Responsibilities
Responsibilities & Key TasksLead global, cross-functional trial teams to ensure successful delivery of complex Phase III studies, with accountability for timelines, quality, and strategic oversight.Serve as the primary contact for internal and external stakeholders regarding trial progress, governance, and issue resolution.Author and manage essential trial documentation including protocols, informed consent forms (ICFs), study management plans, and integrated quality plans.Provide strategic input and make scientific or medical decisions alignment with medical colleagues when applicable.Ensure consistent use of study tools, training materials, and adherence to GCP/ICH guidelines, SOPs, and regulatory requirements.Lead interdisciplinary core trial teams (e.g., data management, statistics, pharmacokinetics, clinical operations) and facilitate Trial Oversight Meetings.Collaborate cross-functionally to support milestone achievement and proactively manage study risks and mitigation strategies.Manage and mentor clinical operations staff, including performance appraisals, development planning, and resolution of employee relations issues.Provide coaching on project planning, risk management, and problem-solving to ensure global alignment and adoption of process and technology tools.Support staff uring quality and compliance with contractual obligations.Monitor and guide financial aspects of trials including scope, budget, schedule, and change control.Conduct regular performance reviews using dashboards and metrics, ensuring accurate reporting and system compliance.Plan trial quality and risk monitoring/ mitigation. Identify and address quality issues withlementing corrective and preventive actions as needed.Perform continuous review, risk identification, evaluation/ analysis and communication on a trial level as applicable.Lead or contribute to corporate initiatives, process improvements, and cross-functional collaborations.Tratems, and competency frameworks to foster continuous development.Consult with pharmacogenetics and safety experts on preclinical data, adverse events (SAEs, SUSARs), and side effect profiles as needed.Demonstrate therapeutic area expertise (e.g., oncology, inflammatory, CMR (cardiovascular-metabolic renal)) and apply clinical pharmacology knowledge to study design and execution.Maintah effective communication and leadership capabilities.REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCEMaster’s or higher-level degree in life sciences or related field. An education as a physician would be a plus.Minimum of 5 years (or 10 years for Senior CTL role) of global clinical operations management experience, preferable within a global CRO environment.Experience protocol writing.Knowledge of applicable clinical research regulatory requirements e.g. GCP / ICH guidelines, CTR and relevant local laws.Therapeutic area knowledge lammatory or CMR would be required and experience in any of the following would be an advantage: respiratory, CNS, ophthalmology.Computer skills including good knowledge of Microsoft Word, Excel and PowerPoint.Fluent language skills in English.Effective communication, organizational and problem-solving skills.Strong leadership competencies and ability to establish and maintain effective working relationships.Required Qualifications & CompetenciesEducation: Master’s degree or higher in life sciences or a related field is required; medical education (e.g., physician) is considered a strong asset.Experience: Minimum of 10 years of relevant experience luding at least 5 years in global clinical operations and trial management with leading a clinical team in a matrix structure, preferably within a global CRO or pharmaceutical environment.Clinical Expertise: Proven experience h deep knowledge of study designs, protocol development. Further experience in Phase II trials is considered beneficial.Regulatory Knowledge: Strong understanding and practical application of clinical research regulatory requirements, including GCP, ICH guidelines, and relevant local laws.Therapeutic Area Knowledge: Familiarity with therapeutic areas such as oncology, inflammatory, CMRLeadership & People Management: Demonstrated ability to lead and manage global clinical teams in a matrix structure, delegate effectively, provide coaching and feedback.Collaboration & Communication: Excellent interpersonal and communication skills, with the ability to work across geographies and cultures, and build strong relationships with internal and external stakeholders.Organizational Skills: Strong planning, organizational, and problem-solving abilities, with a proven track record of managing competing priorities and delivering results to quality and timeline metrics.Customer Focus & Decision-Making: Ability to understand customer needs, navigate complex discussions, and negotiate effective solutions. Demonstrates sound judgment and decision-making capabilities.Learning Agility: Committed to continuous learning and development, with openness to evolving industry practices and technologies.Technical Proficiency: Strong computer skills, including proficiency el, PowerPoint, and clinical trial management systems.Language Skills: Fluent in English.Core Competencies: Demonstrates key competencies such as Client Focus, Collaboration, Communication, Innovation, and Ownership.Extensive experience leading late-stage clinical trials (Phase III) and the ability to quickly integrate into ongoing programsDemonstrated ability to appropriately identify and escalate issues when neededStrong proactive risk management skillsProven capability to effectively manage conflict and navigate challenging situationsExperience working within and successfully navigating complex matrix organizationsExcellent communication and stakeholder management skillsStrong project management capabilities, including:Defining clear expectationsEstablishing realistic timelinesEffective prioritization and time managementMaintaining a logical and organized approach to executionWhere you'll workHome-basedYou’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.CultureCulture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.
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