【Janssen】Japan R&D JCO, Japan Clinical Operation Leader (Individual Manager)

ABS degree or equivalent is required preferably in the Life Sciences (BiologyChemistry Biochemistry Nursing or Pharmacy).

Minimumof 8 years clinical trial experience in the pharmaceutical industry or other relevant experiences and skills may be considered by the hiringmanager when reviewing a candidates eligibility.

Requiresclinical research operational knowledge project planning/management andcommunication skills. Should be flexible and able to manage global and regionalteams in a virtual environment. Excellent leadership/decision-making and strongfinancial management skills are essential to this position as are effectiveleadership skills and a proven ability to foster team productivity and and executes with limited supervision. Experience ofmentoring/coaching others. Ability to support and participate in the trainingdevelopment and evaluate of staff on regular basis. Computer literacy is alsorequired.

Thisposition is responsible for the successful execution of local regional and/orglobal clinical trials for assigned projects/studies; this includes undertakingadequate planning obtaining deliverables within agreed timelines and budgetsensuring high quality and meeting all of the companys Standard OperatingProcedures (SOP) and regulatory requirements. This position leads the JapanClinical Team (JCT) and interfaces with the corresponding Japan Compound Team(JCoT) various teams in Global Clinical Development Operations (GCDO) theClinical Development Team (CDT) and Study Sites (if required). The position isalso responsible for the alignment of goals with organizational objectives asdefined in the Japan Development Plan (JDP). When managing local trials theJCOL performs the role of a GCDO Trial Leader (GTL) in addition JCOLtakes responsibility for a part of a GCDO Clinical Trial Manager (CTM).

1. Thestudy owner and leader of the JCT. The main focus of the assigned studyinvolves trial management supervision planning and coordination. Workingclosely with the JCoT the JCOL must ensure that the Protocol DesignElements/Protocol is made available to JCO/GCDO on time. As part of the End toEnd Process (E2E) this includes trial set-up execution analysis reporting(which includes trial closure) and vendor set up as well as post-studyactivities. Measures study progress against agreed upon timelines andmilestones.

Regardingthe Request for Service (RFS) the JCOL provides operational input fordesigning and implementing the protocol. Provides key assumptions to RFS whenoutsourcing needs/vendors.

2. Ensuresaccurate budget management for assigned trials. This includes ensuring thatvendors and affiliate budgets are tracking according to plan. Updates are madeto account for changes in the scope of the the case of fullyoutsourced trials the JCOL manages and oversees the Contract ResearchOrganization (CRO).

3. Drivethe preparation of recruitment/contingency plans and implement ad campaigns asrequired. Ensures that enrollment commitments meet projected enrollments at theclinical trial level monitors patient recruitment and ensures timely andaccurate documentation communicating study progress and issue escalation.

4. Inlocal trials create and update study-specific documents such as MonitoringGuidelines Informed Consent Form IMP related documentation Blinding Plansite feasibility related documents by collaboration with CTA. Provide inputinto cross functional documents such as Safety related documents Protocol Deviationsand Issue Escalation processes External Service Provider Oversight PlanFiling and Archiving Plan.

5. Ensurescompliance with global health authority regulations and guidelines and internaloperating procedures and processes. Participates in preparing for andconducting Health Authority inspections and internal QA audits. Ensures that the JCT operates in a constantstate of inspection-readiness. Works with Quality Management (QM) liaisons toensure quality oversight of assigned trials using all available tools.

6. Incoordination with the Japan Clinical Program Leader (JCPL) CTA the SRP(Studyresponsible Physician)/CL(Clinical Lead) and/or members of the GCDO/CDT theJCOL is responsible for providing appropriate trial-specific training to the internal/outsourcedtrial team members and the site study staff. He or she works with the JCOT orJCT members to set up and coordinate Investigator Meetings where applicable.

7. Ensuresthat deliverables are provided according to the trial plan. Provides updates toall JCT and appropriate JCoT members on the status of deliverables. Ensuresthat all required reports are generated and made available for real timetracking of the trial status in accordance with the trial plan.

8. Worksclosely with the JCoT JCT various teams in Global Clinical DevelopmentOperations (GCDO) the Clinical Development Team (CDT) the Clinical SuppliesUnit (CSU) QM and external vendor groups.Subject Matter Expert-TAdrug development knowledge.

Contactsinside the company:

InJanssen Japan: JCoT members CPLs and JCT members Regional Heads and theFinance Controller

Inthe Global Team: CDT members and GCDO members

Contactsoutside the company:Multiple vendors site studystaff