Global clinical trial manager (m/f)

Description

• Assist in all aspects of trials, work closely with and also provide regular updates to the global trial leader
• Liaise with key stake holders, e.g. regulatory, clinical trial supplies, data management, quality assurance, legal, finance etc. for study deliverables
• Solid understanding of the international council of harmonisation
• Ensure trial conduct in adherence to GCP, company SOP, local guidelines and policies, e.g. collaborate with CRAs on-site selection and setup, patient recruitment and also data collection
• Participate in investigator meetings and training of CRAs and assist CRAs with addressing study related questions from investigators
• Ensure collection and approval of essential documents and also timely deliver study supplies for the study commencement
• Collaborate regularly with service providers in relation to central labs, IMP management via IVRS to support and address study related issues affecting allocated countries
• Responsibility for the direct management of CRO and ensure that all delegated tasks are executed per GCP, company SOP and local laws within agreed timelines and budget

• Profound experience in clinical trial management and preferably a sponsor and/or CRO with a clear focus on phase I and II
• Solid knowledge of vendor management and budgeting
• Proven field monitoring experience is beneficial
• Knowledge of clinical trial process
• Experience in executing a wide range of trial activities from study start-up to study report
• Experience with working in a global matrix environment
• Ability to lead diverse teams in a global environment
• Proven track record of managing clinical trials in accordance with pre-set timelines, budget and quality expectations
• Fluent English language skills