(Janssen) R&D, Functional Manager for CRAs , Global Clinical Operation Japan (Tokyo)

Position Summary:
The TA Functional Manager(FM) is accountable for strategic and operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements.
The TA FM supports the Local R&D in shaping and managing local organizational structure to ensure its optimal efficiency and demonstrates effective issue management.
This individual is responsible for line management of Site Managers (SMs). Oversees staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports.
Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the assigned therapeutic area(s), country and GCO/ Global Development (GD) overall.
Principal Responsibilities:
1. Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
2. Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
3. Support the flexible resourcing model and collaborate with flex resource managers to get qualified staff in a timely manner, provide feedback on flex staff performance and support their on-boarding and offboarding.
4. Interview, hire, develop and train staff.
5. Ensure understanding of relevant processes and procedural documents supported by documentation of direct reports' training compliance, as required.
6. Support direct reports in issue resolution and communication with involved stakeholders
7. Support local implementation of organizational changes and effectively communicate on priority shifts.8. Review and approve expenses in compliance with the company policies.
9. Demonstrate leadership behaviors in alignment with J&J Leadership Imperatives
10. Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
11. Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
12. Define, execute or support of long term strategy in alignment with GCO(Global Clinical Operation), JJRD(Janssen Japan R&D), GD(Global Development) and Janssen R&D strategies to position the local and global GCO organization for success.
13. Oversight of execution and monitoring of clinical trials through all phases (from feasibility to closeout) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.
14. Ensure relevant operational objectives are met in conformance to ICH-GCP, local regulations, relevant SOPs and other procedural documents.
15. Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach. Contribute to CAPA and issue resolution in accordance with required timelines.
16. Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
17. Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other area of responsibility, as required.
18. Accountable for robust feasibility process and oversight of site qualification process to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
19. Support regular metrics review and drive necessary follow-up actions.
20. Contribute to development, evaluation and implementation of new processes and systems to improve study management.
21. Ensure adequate quality oversight within assigned therapeutic area(s) and/or other area of responsibility, as required.
22. Foster a culture of continuous improvement and innovation within the local GCO team.
23. Model Credo based culture within the local GCO team.
24. Propose and ensure the strategic assignment of SMs within25. Enhance site engagement by utilizing any ideas.
Principal Relationships:
Primary Reporting Structure : Reports to Director Functional Management
Primary interfaces : Site Managers, Clinical Research Managers, other Functional Managers, and supporting roles in the country
Other Internal Interfaces : R&D/Local Operating Company staff (including Medical Affairs), departments within and outside of JJRD/GCO/GD, i.e. Portfolio Delivery Operations, EBIS, IDAR, BRQC, HCC, External Alliances, Contracts & Grants and others as required.
External Interfaces : Functional management of flex providers, Health Authorities, Ethics Committees, investigational sites, local vendors and others as required
Education and Experience Requirements:
Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Minimum of 5 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.
Experience in mentoring/coaching others (line management experience desirable). Skilled in leading, hiring, training, developing and evaluating people. Solid decision-making and financial management skills.
Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to synthesize and evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities, etc.).
Flexible mindset and ability to work in a fast-changing environment. Operates under limited supervision.
Proficient in English language. Computer literacy. Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.
Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated with underlying medical conditions and other circumstances).