Johnson & Johnson Clinical Operations Manager Vacancy – Apply
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science — bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
Job Title: Manager , Global Clinical Operations
Location: Greater Mumbai, India
Department: R&D
Req Id: 2206005952W
Qualifications
- Include any degrees or certifications which are required and/or desirable.) Bachelor’s degree or equivalent required, preferably in Chemistry, Pharmacy. Minimum of 5 years of clinical research experience acquired in the 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 the 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.
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. 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 closeout) and ensuring inspection readiness within assigned therapeutic area(s) and/or another 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 the assigned therapeutic area(s) and/or another area of responsibility, as required.
18. Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within the assigned therapeutic area(s) and strategic goals.
19. Support regular metrics review and drive necessary follow-up actions.
20. Contribute to the development, evaluation, and implementation of new processes and systems to improve study management.
21. Ensure adequate quality oversight within the assigned therapeutic area(s) and/or another 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. This is not an exhaustive, comprehensive listing of job functions.
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