Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Integrated Clinical Operations Analytics. This position can be located remotely within the United States or Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Manager, Integrated Clinical Operations Analytics (ICOA) will contribute to the implementation and execution of business intelligence and analytics strategies in line with the strategic vision of ICOA and Enabling Business Information Systems (EBIS) overall. This individual will partner with Global Clinical Development Operations (GCDO) IT, eClinical platform leads, and contributes to Operational Data Warehouse (ODW), Quality Risk Management (QRM), and Analytical Risk Based Monitoring (ARBM), and optimizes platform usage across GCDO. Provide support for the operation and optimization of the ICOA platform, ensuring that the platform meets the requirements of customers across GCDO and is compliant with applicable regulations. Accountable for systems inspection readiness and provide expertise as necessary for FDA and other health authority inspections. Contribute to initiatives to yield faster and more effective incident management and efficient change management services. Create and maintain a continuous improvement framework with respect to systems deployment, life cycle management and system enhancements supported by greater partnerships with suppliers, Contract Research Organization (CRO) partners and industry user groups. Participate in leading, managing and developing high-functioning, diverse teams. Provide technical expertise in the Business Intelligence (BI) and/or analytical space gained through integrating diverse and complex business processes and associated systems infrastructures. Contribute to leading and managing the business intelligence efforts, within the ICOA team, active in the maintenance and continuous improvement of the platform providing information to facilitate GCDO business Management.
- Facilitate data quality management, integration, reporting, and analytics: Contribute to setting ICOA strategy aligned with ICOA and EBIS vision and GCDO business needs. Work to optimize related systems infrastructure by working with other EBIS teams, GCDO IT, external partners, and vendors. Contribute to the optimization of user management, content management, performance management and lifecycle management related to ICOA in alignment with the direction set by the EBIS Shared Services team. Contribute to the prioritization of system deployment for platforms vacillating Data Quality Management, Risk Based Monitoring, Integrated Reporting and Metrics to Maximize value for GCDO. Lead the process for removing obsolete legacy systems to streamline and align all platforms and systems.
- Focus on Continuous Improvement: Contribute to a culture of continuous improvement and innovation with respect to the current and future integrated BI systems infrastructure to facilitate Data Quality Management, Risk Based Monitoring, Integrated Reporting, and Metrics to optimize the user experience across GCDO and with internal and external partners. Collaborate with other EBIS teams to continuously improve and harmonize approaches to system validation and level 1/2/3 support.
- Create an Internal and External Benchmark: Establish an internal and external benchmarking network facilitating the distillation of best practices from leading organizations externally whilst also identifying and sharing best practices.
- Membership of the EBIS - ICOA Team: Contribute to execution of long-term strategies and the successful achievement of annual goals and objectives of the ICOA Team in line with EBIS, GCDO and Development Management Operations and Analytics (DMOA) imperatives. Provide regular updates and insights to the EBIS - ICOA Leadership Team of the status of initiatives, highlighting operational or scientific roadblocks and proposing potential solutions that will assist in removing the roadblocks.
- Contribute to the leadership, management and development of high-functioning, diverse teams and to aid in building teams to enable industry-leading systems to facilitate integrated reporting and metrics with a focus on delivering value for stakeholders.
- Act as the key leadership mentor.
- Participate in GCDO and cross sector initiatives as assigned.
- This position reports to Head, ICOA; Director, ICOA or Associate Director, ICOA.
- A minimum of a Bachelor's degree is required, preferably in Engineering, Science or Computer Science. Master's degree is preferred.
- A minimum of 6 years of experience working within Business Intelligence (BI) and/or Data Warehouse platforms is required.
- A minimum of 2 years of project management experience is required.
- Experience in clinical development within Pharma and/or Life Sciences is preferred.
- Experience delivering system implementations yielding a positive ROI for organizations preferred.
- Previous experience managing individuals and teams with a proven track record in developing talent is preferred.
- Knowledge of Process Excellence/Six Sigma tools and methodologies is preferred.
- Experience working in a global environment is preferred.
- Strong knowledge of multiple cross-functional eClinical systems is preferred.
- Strong knowledge of Good Clinical Practices (GCPs), International Conference on Harmonization (ICH), and 21 CFR Part 11 is required.
- Must have excellent written and verbal communication skills.
- Must have strong analytical problem-solving and decision-making skills.
- The ability to collaborate will all levels of management across a matrix environment is required.
- This position will require up to 25% domestic and international travel.