【Janssen】 R&D Japan, Clinical Trial Administrator (Manager)

Job description

Job Description

Requisition ID: 1805706340W

【 Janssen 】 R&D Japan, Clinical Trial Administrator (Manager)

JOB SUMMARY ：

・ The focus of this position is to support operational aspects of the Japan Clinical Organization's (JCO)

managed clinical trials. The scope of the work includes tasks associated from JCT formulation to close out,

in all phases of clinical trial development.

・ Lead the sophistication, efficiency, and standardization of operations and processes in JCO.

・ Provide that create integrated document and standardized process to support efficiency and quality

assurance of clinical trial.

・ Gathering information for execute clinical trials and generate information to JCO.

・ Support an inspection.

KEY RESPONSIBILITIES:

Assists JCT member of assigned PTC from JCT formulation until close-out.

・ Reminds JCT member to do activity at each trial milestone action.

・ Creates master SOP related documentation.

・ Creates local specific documentation.

・ Discusses clarify medical expense with Contract & Grants (C&G).

・ Set up a system. (e.g. CTMS, TMS, TMF, Intralinks)

・ Supports to Investigator Meeting.

・ Distributes safety information for head of investigational sites and principal Investigator and manages

distribution list.

・ Creates and management regulatory documents for submission to the country-level Health Authority.

・ Supports activity after study closed.(e.g. IFDF/Destruction Letter/ Approve Letter)

・ Supports filing and archiving(e.g. support of eTMF Quality check)

・ Supports audit / inspection / regulation requirement

・ Supports other JCT related work. (e.g. X-charge/ Minuets of JCT-Meeting)

・ Supports other JCO related work. (e.g. Maintenance of site data base/ Management of imprint)

・ Updates Japan specific SOP document or SOP template form

Desired profile

Qualifications

REQUIREMENTS:
Experience/Knowledge

Good working knowledge of ICH-GCP, company standard operating procedures, local

laws, and regulations.

Skills/Capabilities

■ Be required strong organizational skills and the ability to collaborate and handle

multiple priorities within a matrix environment. Be required perform activities in

a timely and accurate manner.

■ Good organizational skills, and strong communication / negotiation skills in

written and verbal Excellent independent time management skills.

■ A proven ability to plan and track deliverables and timelines.

■ The individual must work well in a dynamic environment and be able to

prioritize and respond to changing business needs.

■ Strategic thinking beyond own function; is familiar with and takes into account

overall business objectives and company strategy

■ Demonstrated excellent leadership and change management skills with focus

on execution and client orientation

■ Flexibility and willingness to take on and lead special tasks and projects as

assigned

■ In additionally, such as below is preferable,

■ Strong experience with outsourcing trials

■ Ability to multi-task and set priorities

■ Strong communication skills and active listening skills with proven application

with clients and internal stakeholders in a solution oriented manner

■ Ability to handle and oversee multiple tasks simultaneously

■ Analytical skills, quick perception and excellent judgment; able to identify risks

and problems, to develop adequate problem solving strategies even in

complex situations, and to take appropriate measures when required

■ Business English (oral and written)

Qualification/Certificate

■ A CTA's / OM's / CC's degree (or equivalent) is required, as well as 1–2 years of

relevant work experience. Although a bachelor's degree is preferred, other

relevant experience and skills may be considered by the hiring manager when

considering a candidate's eligibility.

Primary Location
Japan-Tokyo-To-Chiyoda-
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Clinical Research non-MD
Requisition ID
1805706340W