Clinical Trial Lead

Description

• Leading global cross-functional project team delivery, being accountable for trial oversight, achievement of trial milestones and trial quality.
• Serving as the primary contact within the customer for trial progress and governance.
• Developing study management plans and further documents for complex phase I and phase II trials (including authoring trial protocol and protocol synopsis, ICF, integrated Quality plan, etc.).
• Takes medical and/or scientific decisions (for non-medics in alignment with MD colleagues at the customer) and provides strategic input for early clinical development.
• Ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures.
• Leading (interdisciplinary) of the core trial teams (e.g.: trial data managers, trial statistician, trial pharmacokinetics and clinical trial manager,…).
• Leading the Trial Oversight Meeting (as applicable).
• Collaborating with other functional groups within the client where necessary to support milestone achievement and to manage study issues and obstacles.
• Consulting with pharmacogenetics experts on preclinical and medical aspects as well as side effects (including SAEs and SUSARs).
• Anticipating project risk and implementing mitigation strategies.

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. Please consider this a mandatory requirement.
• Experience in set-up and conduct of Phase II clinical trials including in depth knowledge of early phase study designs, protocol writing and clinical pharmacology. Additional experience in conduct of Phase I and Phase III trials would be an advantage.
• Knowledge of applicable clinical research regulatory requirements e.g. GCP / ICH guidelines and relevant local laws.
• Therapeutic area knowledge in any of the following would be an advantage: respiratory, inflammatory, cardiovascular - metabolic, CNS, oncology.
• 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.