职位详情
Syneos Study Management Associate (PM) 项目经理
4-6万
赛纽仕医药咨询(上海)有限公司
苏州
5-10年
本科
11-25
工作地址

苏州中心在家办公

职位描述
FSP Top Global Pharma (医美项目)


要求:

*1年以上PM项目管理经验, 治疗领域不限

*具有临床项目vendor管理经验(vendor包括但不限于:SMO,医学影像,心电图,Central Lab,EDC,IRT,Drug supply chain等)

*英文听说读写流利(全英文面试)


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.

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