Clinical Trial Lead

IQVIA•Durham, NC

1d•Remote

About The Position

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. The Clinical Trial Lead will lead global, cross-functional trial teams to ensure successful delivery of complex Phase III studies, with accountability for timelines, quality, and strategic oversight. This role serves as the primary contact for internal and external stakeholders regarding trial progress, governance, and issue resolution. The position involves authoring and managing essential trial documentation, providing strategic input and making scientific or medical decisions in early clinical development, and ensuring consistent use of study tools, training materials, and adherence to GCP/ICH guidelines, SOPs, and regulatory requirements. The role also includes leading interdisciplinary core trial teams, collaborating cross-functionally to support milestone achievement, managing and mentoring clinical operations staff, and monitoring and guiding financial aspects of trials. The Clinical Trial Lead will also plan trial quality and risk monitoring/mitigation, lead or contribute to corporate initiatives, and train and support staff on clinical trial processes. Demonstrating therapeutic area expertise and maintaining fluency in English with effective communication and leadership capabilities are essential.

Requirements

Master’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 in set-up and conduct of Phase III clinical trials including in depth knowledge study designs, and protocol writing.
Knowledge of applicable clinical research regulatory requirements e.g. GCP / ICH guidelines, CTR and relevant local laws.
Therapeutic area knowledge in oncology, inflammatory 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.
Master’s degree or higher in life sciences or a related field is required; medical education (e.g., physician) is considered a strong asset.
Minimum of 10 years of relevant experience in clinical research, including 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.
Proven experience in the setup and conduct of Phase III clinical trials, with deep knowledge of study designs, protocol development. Further experience in Phase II trials is considered beneficial.
Strong understanding and practical application of clinical research regulatory requirements, including GCP, ICH guidelines, and relevant local laws.
Familiarity with therapeutic areas such as oncology, inflammatory, CMR
Demonstrated ability to lead and manage global clinical teams in a matrix structure, delegate effectively, provide coaching and feedback.
Excellent interpersonal and communication skills, with the ability to work across geographies and cultures, and build strong relationships with internal and external stakeholders.
Strong planning, organizational, and problem-solving abilities, with a proven track record of managing competing priorities and delivering results to quality and timeline metrics.
Ability to understand customer needs, navigate complex discussions, and negotiate effective solutions. Demonstrates sound judgment and decision-making capabilities.
Committed to continuous learning and development, with openness to evolving industry practices and technologies.
Strong computer skills, including proficiency in Microsoft Word, Excel, PowerPoint, and clinical trial management systems.
Fluent in English.
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 programs
Demonstrated ability to appropriately identify and escalate issues when needed
Strong proactive risk management skills
Proven capability to effectively manage conflict and navigate challenging situations
Experience working within and successfully navigating complex matrix organizations
Excellent communication and stakeholder management skills
Strong project management capabilities, including: Defining clear expectations Establishing realistic timelines Effective prioritization and time management Maintaining a logical and organized approach to execution

Nice To Haves

An education as a physician would be a plus.
Experience in any of the following would be an advantage: respiratory, CNS, ophthalmology.
Further experience in Phase II trials is considered beneficial.

Responsibilities

Lead 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 in early clinical development, in 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 in achieving project deliverables on time and within budget, ensuring 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 within studies, implementing 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.
Train and support staff on clinical trial processes, systems, 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.
Maintain fluency in English, with effective communication and leadership capabilities.