The Functional Manager I (FM I) 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 FM I supports the Local R and D Head 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 Local Trial Managers (LTMs), Site Managers (SMs), Clinical Trial Assistants and/or other GCO staff, as 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.Responsibilities1. 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 andapproveexpenses in compliance with the company policies. 9. Demonstrate leadership behaviours in alignment with J and 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, GD and Janssen R and 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 close:out) 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 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 a
