Johnson & Johnson Careers

【Janssen】Japan Medical Affairs Excellence, Clinical Operation Leader (JCOL)

Chiyoda, Tokyo-To
Medical Affairs


Job Description

Requisition ID: 1805648533W

【Janssen】Japan Medical Affairs Excellence, Clinical Operation Leader (JCOL)

 

POSITION SUMMARY:

This position is accountable for leading with successful execution of local, regional, and/or global data generation activities for assigned projects/studies; this includes undertaking adequate planning, obtaining deliverables within agreed timelines and budgets, ensuring high quality, and meeting of all the company's Standard Operating

Procedures (SOP) and regulatory requirements. When managing local trials, the JCOL performs the role of a GCDO MAO Trial Leader (GTL) in GCDO. In addition, JCOL takes responsibility for a part of a GCDO MAO Trial Manager (TM).

 

PRINCIPAL RESPONSIBILITIES:

1. The study owner and leader of the JCT. The mainly focus of the assigned study involves trial management supervision, planning, and coordination. Working closely with Medical Affairs teams. As part of the “End to End Process” (E2E), this includes trial set-up, execution, analysis, reporting (which includes trial closure) and vendor set up, as well as post-study activities. Measures study progress against agreed upon timelines and milestones.

Regarding the Request for Service (RFS), the JCOL provides operational input for designing and implementing the protocol. Provides key assumptions to RFS when outsourcing needs/vendors.

2. Is accountable for delivery of assigned trials within agreed/projected life of trial budget.

Ensures accurate budget management for assigned trials. This includes ensuring that vendors and affiliate budgets are tracking according to plan. Updates are made to account for changes in the scope of the trial. In the case of fully outsourced trials, the JCOL manages and oversees the Contract Research Organization (CRO).

3. Tracks project progress against planned timelines. Monitors patient recruitment rate to ensure that target enrollment will be met across the allocated regions/countries.

Provides regular status updates to Medical Affairs teams, project owners and Clinical Team members. Ensures required reports are generated and available for real time tracking of project states.

4. In local trials, create and update study-specific documents such as Monitoring

Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, site feasibility related documents. Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan.

5. Ensures compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participates in preparing for and conducting Health Authority inspections and internal QA audits. Ensures that the JCT operates in a constant state of inspection-readiness. Works with Quality Management (QM) liaisons to ensure quality oversight of assigned trials, using all available tools.

6. In coordination with the Japan Clinical Program Leader (JCPL), the SRP/SRS (Study responsible Physician/Study responsible Scientist), Medical Affairs teams and/or members of the GCDO/CDT, the JCOL is responsible for providing appropriate trial-specific training to the internal/outsourced trial team members and the site study staff. He or she works with Medical Affairs teams or JCT members to set up and coordinate Investigator Meetings, where applicable.

7. Ensures that deliverables are provided according to the trial plan. Provides updates to all JCT and Medical Affairs teams on the status of deliverables. Ensures that all required reports are generated and made available for real time tracking of the trial status, in accordance with the trial plan.

8. Works closely with Medical Affairs teams, JCT, various teams in Global Clinical Development Operations (GCDO), QM, the Clinical Supplies Unit (CSU) if need and external vendor groups. Subject Matter Expert-TA drug development knowledge.

 

PRINCIPAL RELATIONSHIPS:

Contacts inside the company:

In Janssen Japan: JCoT members, CPLs, and JCT members, Regional and Country Medical Affairs teams, Legal, Finance, QS, Quality Management & Training group, Quality Assurance group, Procurement(JRP), Project Owners and other J&J enterprise sectors, as applicable.

Contacts outside the company:

Multiple vendors, clinical investigative sites and their research staff.



Qualifications

EDUCATION AND EXPERIENCE REQUIREMENTS:

A BS degree or equivalent is required, preferably in the Life Sciences (Biology, Chemistry, Biochemistry, Nursing, or Pharmacy).

Clinical trial experience in the pharmaceutical industry or CRO. However, other relevant experiences and skills may be considered by the hiring manager when reviewing a candidate’s eligibility.

Requires clinical research operational knowledge, project planning/management, and communication skills. Should be flexible and able to manage global and regional teams in a virtual environment. Excellent leadership/decision-making and strong financial management skills are essential for this position, as are effective leadership skills and a proven ability to foster team productivity and cohesiveness.



Primary Location
Japan-Tokyo-To-Chiyoda
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Medical Affairs
Requisition ID
1805648533W