Senior Clinical Project Manager (m/f)

Description

• Involvement in all aspects of trials, working closely with and also providing regular updates to the Global Trial Manager
• Liaise with key stake holders e.g. Regulatory, Clinical Trial Supplies, Data Management, Quality Assurance, Legal, Finance etc. for study deliverables
• Collaboration with HQ and local affiliate staff to ensure receipt of Health Authority, Regulatory Authority, Ethics Committee, Hospital and Investigator Agreement Approvals, prior to study start
• Ensure trial conduct in adherence to GCP, company SOP, local guidelines and policies
• Collaboration with CRAs on site selection and setup, patient recruitment and also data collection
• Participation in investigator meetings and training of CRAs and assisting CRA to address study related questions from investigators
• Ensure collection and approval of essential documents and also timely delivery of study supplies for study commencement
• Involvement in the development, review and approval of study documents
• Collaboration with service providers in relation to Central Labs, IMP Management via IVRS, ECG assessments and Echo assessments to support and address study related issues affecting allocated countries
• Direct management of CRO, ensuring all delegated tasks are executed per GCP, Company SOP and local laws, within agreed timelines and budget
• Proactively maintain issue log to track all identified issues and ensure timely and cost effective resolution of issues on an ongoing basis

• Solid experience in clinical trial management
• Solid knowledge in vendor management and budgeting
• Proven field monitoring experience preferred
• Good overview of clinical trial processes
• Experience in executing a wide range of trial activities from initiation to study report
• Experience working in a global matrix environment