Manager , Global Clinical Operations

  Regulatory Affairs

Job title: Manager , Global Clinical Operations

Company: Johnson & Johnson

Job description: 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. E

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. Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world. Janssen recognizes the impact of serious conditions on people’s lives, and aims to empower people through disease awareness, education and access to quality care in six therapeutic areas. Position Title* : 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), 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. 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 behavioursin 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 trialsthrough all phases ( from feasibility to closeout) 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 metricsreview 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. Principal Relationships: (Describe the primary working relationships (internal & external) and primary interfaces) 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/GD, 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 Qualifications Education and Experience Requirements: (Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.) 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 requirementsincluding ICH-GCP, HCC and applicable regulations. Ability to synthe and evaluate data generated from variousreports and sources. Demonstrated skillsin 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. Are you ready to impact the world Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Primary Location India-Maharashtra-Greater Mumbai- Organization Johnson & Johnson Private Limited (8080) Job Function R&D Requisition ID 2206005952W

Expected salary:

Location: Mumbai, Maharashtra

Job date: Thu, 03 Feb 2022 23:04:36 GMT

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