Director of Data Management and Central Monitoring Reporting

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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.

Responsibilities:

• 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.

Qualifications:

Required:

• 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.

Other: Travel: less than 10%

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Raritan, NJ, Titusville, NJ, Springhouse, PA- Requisition #: R-006298 Beerse- Requisition #: R-011027 High Wycombe - Requisition #: R-011024 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.