Clinical Trial Manager

Position Name : Clinical Trial Manager

Location : Tokyo or Osaka, Japan

This is an exciting opportunity to join ICON as Clinical Trial Manager.

 
Our Clinical Trial Managers act as the Functional Lead from Clinical Operations with responsibility for delivery of all Clinical Operations aspects of clinical studies ensuring consistency with ICON SOPs, study contracts and budgets. This role is based in Japan and you will be required Japanese language fluency and High-business level English. 

Overview of the role :

As a Clinical Trial Manager at ICON, you will :

• Identify, select, initiate and close-out appropriate investigational sites for clinical studies.

• Monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/WPs applicable regulations and the principles of ICH-GCP.

• Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues .

Job Description :

• Recognize, exemplify and adhere to ICON"s values which center around our commitment to People, Clients and Performance.

• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

• Ability and willingness to travel at least 60% of the time.(lnternational and domestic : fly and drive)

• Expert knowledge of ICON's SOPs/WPs, ICH, GCP and appropriate regulations.

• Familiarity with ICON systems .

• Maintain timelines .  Ensure accuracy and completeness of data entered into ICON systems.

• Recruitment of investigators .

• Independent and proactive coordination of all the necessary activities required to set up and monitor a study , including but not limited to the following :

　　>> Identify investigators.

    >> Help when requested , in preparation of regulatory submissions . Design of patient information sheets and consent forms . 

    >> Ensure timely submission of protocol/consent documents for ethics/IRB approval. Pre study/placement and initiation visits. Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/sponsor site monitoring SOP, as appropriate

・Maintain all files and documentation pertaining to studies . Motivate investigators in order to achieve recruitment targets. Complete accurate study status reports.

・Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.

・Keep the Project Manager regularly informed.

・Process case record forms to the required quality standards and timelines . Deal with sponsor generated queries in a timely manner.

・Ensure the satisfactory close-out of investigator sites .

・Participate, if requested, in the preparation of and review of study documentation , e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.

・Participate in feasibility studies for new proposals as required. Ensure correct archiving of files on completion of a study .

・Maintain patient and sponsor confidentiality .

・Assume additional responsibilities as directed by the Project Manager.

・lnvestigational Products (IPs) stored and managed by the site:

　　>> Ensure storage conditions and acceptable supplies are provided

    >> Ensure IPs are supplied only to eligible patients

    >> Ensure IP receipt, use and return are controlled and documented

    >> Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.

• Act in a lead role on a study assuming additional responsibilities as   detailed/documented by the Project Manager if appropriate .

• Participate in data listing reviews, as applicable .

• Responsible for cost effectiveness

• Participate in training and mentoring new staff up to Clinical Research Associate level as appopriate.

• Assist with marketing the company if and when appropriate . Other duties as assigned.

Benefits of Working in ICON :

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career. 

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.