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For your reference, we have included the original job posting below.
GSS Specialist I
Job Number:
23010913
Company Name:
Covance
Job Location:
Beijing, CN
Job Category:
Healthcare & Medical
GSS Specialist I
Business Title GSS Specialist I Requisition ID 20786BR Job Category Clinical Research Locations China, Beijing Shift 1 Job Posting At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. Covance's ongoing success offers team members unsurpassed growth and career development opportunities. There's no better time to join us! Responsibilities: . Delivery of the Global Site Services (GSS) component of assigned studies within a country or globally. Including accountability for delivery to time, cost and quality for assigned activities . Primary contact with investigative sites during site start-up activities . Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor . Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial. . Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials . Where applicable, provide logistical support of clinical trial supply coordination Education/Qualifications University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 3 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations. In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered. Experience . Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites . Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe . Good organizational and time management skills . Excellent communication / writing skills . Strong computer skills with an ability to access and leverage technology alternatives . Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies . Self-motivation with the ability to work under pressure to meet deadlines . Works well independently as well as in a team environment . Detail and process oriented . Positive attitude and approach . Multi-tasking capability . Ability to work independently
