Clinical Trial Lead
Job Title: Clinical Trial Lead
Job Location: Durham, North Carolina, United States of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Job Posting Title- Clinical Trial Lead
Location: Home-based in the U.S.
Responsibilities & Key Tasks
• 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.
REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE
• 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.
Required Qualifications & Competencies
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