Senior Clinical Project Manager (m/f)

REFERENZNUMMER:

245602/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Clinical trial manager