Seoul, KOR
1 day ago
Clinical Project Assistant (12mths FTC)
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** With guidance, performs or supports other Clinical Operations team members in the start-up, maintenance and close-out of clinical studies (clinical trials and PMS studies). Tracks and prepares study-specific information, reviews and participates in the quality assurance of data and/or documents, arranges and assists with meetings and meeting logistics, and assists with development of documents and standard forms. **RESPONSIBILITIES:** + Performs study activities including start-up, maintenance and close-out with other Clinical Operations team members’ oversight and guidance. + Performs eTMF functional QC and CRO oversight QC. + Performs study document upload to Trial Master File or other repositories. + Reviews and participates in the quality assurance of data or documents. + Assists with development of documents and standard forms. + Arranges study meeting logistics, agendas, and assists with minutes + Tracks and prepares study-specific information using databases, spreadsheets, and other tools. + Maintains internal Clinical Operations databases, Tools and document repositories + Supports administrating the budget and financial management of study activities, under responsibility of the executives concerned. + May act as a local subject matter expert (SME) or SPOC for a specific focus area e.g. eTMF/TMF, CTMS, budget, document archiving, etc. + Interacts with other departments, as needed, to complete assigned tasks. + Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements. **REQUIREMENTS:** **- Minimum Education & Experience** + Mandatory: 1 or more years’ relevant work experience – SSU (Study Start-up) or CTA (Clinical Trial Assistant) from Pharma/CRO or Study Coordinator from investigational sites. + BA / BS / RN + Some general clinical or business knowledge and experience is preferred. **Knowledge & Other Requirements** + Knowledge of local country regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures + eTMF, CTMS & budget support experiences preferred. + Demonstrated ability to be a fast learner. + Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. + Understands how to use basic office programs / tools. + Ability to communicate in a clear and concise manner. + Ability to support a team-oriented, highly matrixed environment. + Ability to execute multiple tasks as assigned + Excellent verbal and written in Korean and English skills, and interpersonal skills are required. + Works proactively under minimal supervision. **For Current Gilead Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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