職位描述
臨床試驗醫美
FSP Top Global Pharma (醫美項目)
要求：
*1年以上PM項目管理經驗, 治療領域不限
*具有臨床項目vendor管理經驗（vendor包括但不限于：SMO，醫學影像，心電圖，Central Lab，EDC，IRT，Drug supply chain等）
*英文聽說讀寫流利（全英文面試）
Primary Job Function 要求：
*1年以上PM項目管理經驗, 治療領域不限
*具有臨床項目vendor管理經驗（vendor包括但不限于：SMO，醫學影像，心電圖，Central Lab，EDC，IRT，Drug supply chain等）
*英文聽說讀寫流利（全英文面試）
-Matrix management of functional areas and/or study vendors to ensure clinical study(ies)execution occurs per timelines.
-Is aware of both internal and external business environments and their impact on studies.
-Escalates issues to management with possible solutions.
Core Job Responsibilities
-Assist in the coordination of activities across- studies. Ensure all activities are done on time and within budget. This may include assigned study region(s) functional team to ensure the initiation, conduct and completion of one or more clinical programs.
-Prioritize activities to ensure study goals are met.
-Lead study activities such as protocol preparation, investigator selection, site budget/contract development, investigator meeting, vendor selection, CRF design, specification review/approval, and monitoring oversight.
-Leads cross-functional meetings.
-Identify issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions or solutions to manage the issues.
-Experience with all major study milestones (study startup, database cleaning/locks, study closure)
-Past experience in project management(doing the day-to-day aspects: not overseeing the project/program)
Position Accountability/Scope
-This is the second level position (of 3 levels) within a job family which supports clinical study execution and a position which will have some oversight and guidance.
-This position will report into Study Project Manager and will have no direct reports but will begin to matrix manage a team.
-This position may develop site study budgets with a manager’s final approval and approve payments to sites/vendors after comparing invoice against an executed contract.
Requirements
-Must have 4+ years of Pharma-related/clinical research related experience.
-Must have demonstrated a high level of core and technical competencies. Significant experience with relevant systems and software is strongly preferred (ie: RAVE, Excel.)
-Possesses good communication skills.
-Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
-Extensive experience in study initiation through study completion.
工作地點
杭州西湖區學院路(地鐵站)在家辦公
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賽紐仕醫藥咨詢(上海)有限公司Syneos Health賽紐仕醫藥是一家全面整合生物制藥解決方案的公司，旨在幫助客戶加快推出新療法的速度。我們站在產品研發的角度，戰略性地融合臨床研發、醫學事務和商業能力，以及時應對市場變化。Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge- instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
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