Clinical Research Manager

Global Clinical Operations (GCO)

Position Title: CLINICAL RESEARCH MANAGER (Functional Manager II)

**Position Summary**:
The Clinical Research Manager (FM II) 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. Supports Local R&D Head in shaping and managing local organizational structure to ensure its optimal efficiency.

This individual is responsible for line management of Local Trial Managers (LTM), Site Managers (SM), Clinical Trial Assistants (CTA) and/or other GCO staff, as required. Responsible for mentoring more junior FMs and assume cross border oversight (if required). 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 off-boarding.

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 behavioursin 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. Support execution of long term strategy in alignment with GD and Janssen R&D strategies to position the country for success Define, execute or support of long term strategy in alignment with GCO, GD 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, 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 selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.

19. Support regular metricsreview 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

**Principal Relationships**:
Primary Reporting Structure: Reports to Director Functional Management or Local R&D Head

Primary interfaces: Local Trial Managers, Site Managers, Clinical Trial Assistants, Local R&D Head, other Functional Managers, Global Product Lead/Global Trial Lead, Regional Therapeutic Area Lead and supporting roles in the country

Other Internal Interfaces: R&D/Local Operating Company staff (including Medical Affairs), departments within and outside of GCO/GD, i.e. Portfolio De