职位描述
职位描述： Key Accountabilities?Accountable for day to day activities of all aspects for the management of local company-sponsored studies, including study plans, timelines, resources, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams?Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment?Develop and monitor study budget and timelines?Monitor work to ensure quality?Ensures that trials are entered into the Clinical Trial Management System and other systems, if applicable Main Tasks?Understanding of local / country requirements for clinical trials?Managing and steering CROs?Networking skills to represent Merck Serono with key local stakeholders?Proactive issue monitoring and management?Manages the budget for all local clinical studies and Global Phase IV studies assigned?Coordinate within own country study management for all local clinical trials across all phases and therapy areas and for Global Phase IV trials?Support local organization in delivering local medical strategy across the portfolio within own country?Work with CRO in county to ensure local trials are delivered within desired quality, timelines, and costs?Overseeing external providers?Act as interface between Global Clinical Operations and local organization (Global Operations Pre-requisites?Medical or Life Sciences degree or equivalent qualification?At least 3 years of experience in clinical research in a CRO, pharma or biotech company?Experience in clinical trial planning and conduct?Thorough knowledge of ICH GCP and applicable local regulations?Demonstrated good interpersonal skills?Demonstrated good written and verbal communication skills?Demonstrated good presentation skills?Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way?Analytical skills, quick perception and good judgment?Fluency in English (oral and written) plus local language 职能类别： 临床研究员 生物工程/生物制药 关键字： clinical research CRO phase IV ICH GCP trail
3-4年经验 
本科 
招1人 
11-09 发布
