Clinical Trial Lead

About this role

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 •            Education: 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 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. •            Clinical Expertise: 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. •            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, CMR •            Leadership & 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

Similar jobs

• Clinical Trial Leader — Parexel · Remote
• Clinical Trials Manager — Gilead Sciences · Foster City, California, United States
• Clinical Trial Associate — Axsometherapeutics · Remote
• Clinical Trial Manager — Alpha9oncology · Boston, Massachusetts, USA
• Clinical Trial Manager — Heartflowinc · Remote
• Clinical Trial Manager — Caredxinc · Brisbane, CA
• Senior Clinical Trial Manager — Eightsleep · Boston Area
• Senior Clinical Trial Manager — Aditumbio · Cambridge, Massachusetts or Oakland, California