Overview
As Clinical Trial Leader you drive the operational performance of global Phase III trials, guiding cross-functional teams to deliver on timelines, quality, and budget. You act as the primary contact for stakeholders and ensure rigorous GCP/ICH compliance while shaping study design and strategic decisions. You mentor staff, oversee trial documentation, and optimize processes with tools and analytics to support ambitious project goals.
Verantwortungsbereiche
- Lead global, cross-functional trial teams to deliver complex Phase III studies with focus on timelines, quality and strategic oversight
- Serve as primary interface for internal and external stakeholders on trial progress, governance, and issue resolution
- Author and manage essential trial documentation (protocols, ICFs, study management plans, quality plans)
- Provide strategic input and medical decisions in early development in alignment with medical colleagues
- Ensure adherence to GCP/ICH, SOPs, and regulatory requirements across studies
- Lead interdisciplinary core trial teams (data management, statistics, PK, clinical operations) and facilitate Trial Oversight Meetings
- Collaborate cross-functionally to hit milestones and proactively manage risks and mitigations
- Manage and mentor clinical operations staff, including performance and development planning
- Coach on project planning, risk management, and adoption of processes and technology tools
- Monitor trial budgets, scope, schedule and change control; ensure deliverables on time and within budget
- Plan trial quality and risk monitoring; implement CAPAs as needed
- Provide staff training on processes, systems, and competency frameworks
- Consult with pharmacogenetics and safety experts on preclinical data, SAEs, SUSARs and side effects
- Demonstrate therapeutic area expertise (oncology, inflammatory, CMR) in study design and execution
Zentrale Anforderungen
- Master’s or higher degree in life sciences; physician would be a plus
- Minimum of 5 years (10 years for Senior CTL) of global clinical operations management, preferably in a CRO
- Experience in setup and conduct of Phase III trials including design and protocol writing
- Knowledge of GCP/ICH CTR and local regulatory requirements
- Therapeutic area experience in oncology, inflammatory or CMR; experience in respiratory, CNS, ophthalmology is advantageous
- Proficient in Microsoft Word, Excel, PowerPoint
- Fluent in English
- Strong communication, organizational and problem-solving skills
- Strong leadership and stakeholder management abilities
- Proven ability to manage competing priorities and deliver on quality and timelines
- strong communication
- organizational excellence
- problem-solving
- GCP/ICH knowledge
- protocol writing
- study design
Clinical Trial Lead (m/w/d) in Wiesbaden Arbeitgeber: IQVIA
IQVIA ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in New Orleans die Möglichkeit bietet, in einem dynamischen und unterstützenden Umfeld zu arbeiten. Mit einem starken Fokus auf berufliche Weiterentwicklung und einem flexiblen Arbeitsmodell fördert das Unternehmen eine positive Work-Life-Balance und ermöglicht es den Flex Nurse Educators, Patienten durch innovative Bildungsansätze zu unterstützen. Die Unternehmenskultur legt Wert auf Teamarbeit und Vielfalt, was IQVIA zu einem attraktiven Arbeitsplatz für engagierte Fachkräfte macht.
