Johnson & Johnson Innovative Medicine is recruiting for a Director, Data Management and Central Monitoring Reporting to be located in Beerse, Belgium; High Wycombe, England; Raritan, NJ; Springhouse, PA; or Titusville, NJ. Purpose The adoption of risk-based methodologies and analytics is a key area of innovation and growth in Clinical Trial Data Management, Central Monitoring and Global Clinical Operations. The Director Data Management and Central Monitoring Reporting leads our existing group of Central Monitoring Report Experts who support the design and deployment of Clinical Data Central and Analytical Monitoring Analytics Tools and methods for use at trial, program and cross program level. This role will have the opportunity to advance and evolve the capabilities of this team to support and deliver new analytics capabilities to meet planned and anticipate future business needs in support of our clinical trial delivery ecosystem. You will be responsible for:

• Accountable for the strategy, planning, and execution of departmental goals within assigned area and scope ensuring a strong focus on adherence to budget, quality, and compliance standards.
• Ensure alignment with customer and partner functions on Data Management and Central Monitoring reporting strategy closely developing and maintaining collaborative cross department relationships.
• As part of the Departmental Leadership Team, contribute to and champion decisions on departmental strategy, priorities, processes, technologies and sourcing strategy. Partners with cross-functional leadership to resolve customer concerns and champion standard methodologies.
• Identify and implement improvement, optimization, and innovation opportunities with a focus on data analytics in alignment with departmental standards, strategies, and processes.
• Proactively evaluate resource demand, allocation, and utilization to meet current and future needs for programs and projects in line with global portfolio and strategic priorities.
• Contribute to development, collection and analysis of performance metrics and identify ways to raise department standards. Ensure adherence of staff and activities with company and department SOPs and policies, and regulatory requirements.
• Effectively represent and advance the mission of Data Management and Central Monitoring in internal cross-functional/sector level meetings as well as external industry organizations and professional forums.
• Proactively create a purpose driven environment by aligning Johnson & Johnson's Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.
• Drives organizational growth and development through management of assigned personnel including local administration, hiring, development, training, performance management in line with departmental standards and budgets.
  
  Bachelor's degree (e.g., BS, BA) or equivalent professional experience, preferably in relevant Scientific, Computer Science or Analytics related field.
• Approx. 10 years + years of experience in Pharmaceutical Development or relevant field.
• Authoritative knowledge of data analytics, data management and/or Central monitoring concepts, processes, and tools including risk-based quality approaches and methods.
• Consistent track record of leading teams to successful outcomes fostering team productivity and cohesiveness.
• Established track record working successfully in a complex multi-functional environment collaborating with partners, customers, and external vendors.
• Expert knowledge of regulatory guidelines (e.g., ICH-GCP) and clinical R&D concepts.
• Applied understanding of project management concepts, sourcing strategies and resource management.
• Proven experience in process development and improvement and/or technology enhancement.
• Excellent influencing and decision-making skills.
• Excellent written and verbal communications skills (in English).
Preferred:
• Approx. 5 years demonstrated ability in people leadership/management including hiring, talent development and performance management.
• Advanced knowledge and experience in clinical and/or operational data analytics, tools, technologies and methods.
  
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