Manager Clinical Operations

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Position Title: Manager Clinical Operations (Clinical Research Manager)

Position Summary:

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&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) Clinical Research Associates (CRAs) 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.

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 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 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 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 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.

Education and Experience Requirements:

• Bachelors 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. Experience in start-up is an advantage not a requirement.

• 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.

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