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Clinical Operations Manager
hace 2 meses
We are seeking a highly skilled Clinical Operations Manager to join our team at Reconocida empresa. As a key member of our Clinical Operations department, you will be responsible for the operational management and successful country execution of all phases of clinical trials within assigned therapeutic areas or specific roles.
Key Responsibilities- Provide line management to direct reports, including setting goals and objectives, performance evaluation, and talent development.
- Evaluate and forecast resource needs for assigned portfolios and/or other specific areas of responsibility, as required and agreed with local management.
- Responsible for the deployment of the One Delivery Model through collaboration and oversight of vendors.
- Accountable for the acquisition of new talents and development of human resources.
- Guide direct reports in issue resolution and communication with involved stakeholders.
- Lead organizational changes and effectively communicate on priority shifts as required.
- Review and approve expenses in compliance with company policies.
- Demonstrate leadership behaviors in alignment with J&J Leadership Imperatives.
- Foster an environment that encourages sharing of ideas, information, and best practices.
- Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
- Define, execute, or support long-term strategy in alignment with GCO, GD, and JJIM R&D strategies to position the local and global GCO organization for success.
- Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic areas and/or other areas of responsibility, as required.
- Accountable for ensuring relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs, and other procedural documents.
- 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.
- Shape and maintain strong relationships within local GCO departments and Local Operating Companies (particularly with Medical Affairs) and other key internal and external stakeholders.
- Develop country capabilities for an effective study placement within assigned therapeutic areas and/or other areas of responsibility, as required.
- Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic areas and strategic goals.
- Review operational and quality metrics regularly and drive follow-up actions as appropriate.
- Drives innovative solutions and process improvements for the assigned therapeutic areas, country, and GCO/GD overall. Foster a culture of continuous improvement and innovation within the local GCO team.
We are looking for a highly motivated and experienced Clinical Operations Manager with a strong background in clinical research operations and regulatory requirements. The ideal candidate will have:
- Bachelor's degree or equivalent in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, 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.
- Excellent knowledge of drug development, clinical research operations, and regulatory requirements, including ICH-GCP, HCC, and applicable regulations.
- Ability to evaluate data generated from various reports and sources.
- Demonstrated skills in effective communication with various internal and external stakeholders.
- Influential in improving the clinical research environment at a country level.
- Visionary leader who can shape the organizational culture to improve adoption of future state.
- Experience in mentoring/coaching (line management experience desirable).
- Proficient in decision-making and financial management.
- 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.
