FSP Top Global Pharma (醫(yī)美項(xiàng)目)
可接受全國任何城市homebased
要求:
*1年以上PM項(xiàng)目管理經(jīng)驗(yàn), 治療領(lǐng)域不限
*具有臨床項(xiàng)目vendor管理經(jīng)驗(yàn)(vendor包括但不限于:SMO,醫(yī)學(xué)影像,心電圖,Central Lab,EDC,IRT,Drug supply chain等)
*英文聽說讀寫流利
Primary Job Function
-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.