Clinical Trial Lead (m/w/d)

As Clinical Trial Leader (m/w/d) you will be accountable for the operational performance of the trial (preparation, initiation, conduct, close-out and reporting). As such you will manage cross-functional trial teams at the customer, acting as that accountable point for delivery and quality whilst maintaining financial control. You will be supported by domain experts in every function, enabled by best-in-class technology and data analytics.

MAIN 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.

• 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.

• 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.

REQUIRED SKILLS AND QUALIFICATIONS

• 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 o ncology, 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.

• Strong planning, organizational, and problem-solving abilities, with a proven track record of managing competing priorities and delivering results to quality and timeline metrics.