>>>Location：Beijing/Shanghai
【Responsibilities】
·The clinical study manager is accountable for planning, executing and reporting on a number of phase I-IV clinical studies from planning and site feasibility through study close-out, in compliance with processes and regulatory requirements with coordinating with CRAs；Recognize potential challenge within the protocol and operational aspects of the trial and escalate to manager as appropriate/decide on appropriate action.
·Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors，sites and local internal personnel Coordinates and manages the site selection process in collaboration with the related stakeholders.
·Ensure that study start-up activities and any amendments are conducted and completed on time, including preparation of IRB/EC submission packages, working with regulatory affairs for Health Authorities submissions.
·Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents.
·Provide training as needed for monitors and any other activities that support site readiness to recruit.
·Ensure documentation of training is archived appropriately.
·Conduct local investigator meetings as needed.
·Drive the conduct of the trial, track and oversee progress and status.
·Ensure all operational aspects are on schedule.
·Oversee local clinical team activities to achieve trial timelines and quality execution according to standards and local and international regulations.
·Appropriately escalates issues in a timely manner and ensures resolution. Communicate with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics.
·Lead and chair study team meetings, attend and participate other related meeting;Track trial budget with appropriate trial budget.
·Accountable for coordinating data management activities through the study team；
Ensure that all trial close–out activities are performed, in close cooperation with the monitors；
Oversee local vendor selection and performance as needed. Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required；
Facilitate internal audits and HA inspections as required.
·Review the monitor’s visit reports.
·Conduct co-monitoring visit to field monitors from project perspective to ensure trial’s quality and milestone achievement where needed.
·Mentor/coach monitors and sites as required. As senior CSM, will take the mentor role to new CSM.
【Qualification】
·Graduate degree in clinical or pharmacology related fields, Bachelor degree or above；Ideally 5 years work experience with 3+years’experience in clinical research.；Experience in a monitor role or the role overseeing clinical trials.
·Fluent in speaking, writing and reading in local languages, English written and spoken preferred.
·Strong Interpersonal skills, Strong Project Management and leadership skills.
·Ability to work in a matrix environment under pressure.
>>>Contact Information：
联系人：Stephen Yu
邮箱：stephen.yu@isaac-kenneth.com
