At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough. Position Summary:
The Clincial Research Assoicate 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 Clinical Research Associate 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), 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 Clinical Development Organization (GCDO) 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 behaviours 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, GCDO 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. This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. 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/GCDO, i.e. Portfolio Delivery Operations, EBIS, IDAR, BRQC, HCC, External Alliances, Contracts & Grants and others as required. External Interfaces: Functional management of flex providers, Health Authorities, Ethics Committees, investigational sites, local vendors and others as required QualificationsEducation and Experience Requirements: Bachelor's 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. 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. Primary LocationBrazil-São Paulo-São Paulo-OrganizationJanssen Cilag Farmaceutica Ltda. (7585)Job FunctionR&DRequisition; ID2105994243W This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.