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Job Description:

Integrated Data Analytics and Reporting (IDAR)

Manager Central Monitoring*

Central Monitoring Reporting Expert

(*Title may vary based on Region or Country requirements)

Position Summary:

The Manager Central Monitoring is a highly experienced individual contributor role with an in-depth knowledge of Central Monitoring and Analytical Risk Based Monitoring (ARBM) practices, data analytics, methods, processes, and technologies.

The Manager Central Monitoring is accountable for the oversight, execution, and management of central monitoring processes and ARBM activities for one or more compound(s)/program(s), functional domains and/or strategic initiative(s) in conformance to all relevant laws, regulations, guidelines, policies, and procedures. This role may have responsibility for overseeing a Central Monitoring/Central Monitoring Reporting Expert team in a matrix structure.

The Manager Central Monitoring makes central monitoring and ARBM-related recommendations and decisions for specific programs, trials, or assignments that can have an impact on study processes and oversight of study participant safety and data quality. They typically work with minimal direction from their functional manager and/or Central Monitoring/Central Monitoring Reporting Leader.

This position supports the delivery of innovative methodologies and technical and process solutions that directly contribute to the effectiveness of delivery of the J& J Research and Development portfolio, applying change leadership and effective change management methodologies.

This position collaborates closely with other Central Monitoring and Data Management roles, Clinical Programming roles, internal partner functions and/or external service providers to achieve successful, cooperative partnerships. This position may recognize opportunities and contribute to solutions to strengthen the external service providers relationship.

The Manager Central Monitoring/Central Monitoring Reporting Expert mentors and coaches other Central Monitoring roles and may delegate work accordingly.

Principal Responsibilities:

• Oversees, executes, and manages central monitoring activities within assigned scope of responsibility including set-up, execution and close-out as outlined in the end-to-end process in line with portfolio timelines and priorities.
• May be accountable for oversight, management, and/or training of central monitoring experts for all central monitoring activities applicable to scope.
• Maintains risk management and/or central monitoring standards and supports improvements of internal technology and processes.
• May assist with the hiring and training of departmental staff.
• May actively participate in or lead innovation or process improvement projects which may include but are not limited to requirements development, user acceptance testing and identification of improvements to existing and new analytical tools.
• May participate in cross-departmental initiatives or serve role as a (Lead) Subject Matter Expert.
• Facilitates smooth and effective communication, managing multiple communication streams and influencing key cross functional stakeholders. Follows agreed escalation pathways where needed.
• Conducts activities in compliance with J& J and Central Monitoring SOPs, processes and policies.

Central Monitoring Reporting Expert role-specific responsibilities:

• Executes and leads central monitoring reporting activities, which may include the development and oversight of study specific reporting needs, analysis of Central Statistical Surveillance (CSS) and/or enhancements of existing analytical tools across multiple often high complexity trials.
• Accountable for delivery of study-specific configuration activities including reporting specifications, platform configuration, implementation, and maintenance.
• Serves as the primary point of contact for design, review, testing and implementation of required outputs in support of study defined data review requirements and review methods.
• Maintains risk management standards and supports improvements of internal technology and processes.
• In collaboration with Functional Leadership supports the ARBM data reporting strategy utilizing appropriate sourcing and operating model for assigned trials and programs.

Principal Relationships:

• Functional contacts within IDAR include but are not limited to Functional Leadership, Data Management Leaders, Global and Clinical Data Managers, Data Acquisition Experts, Clinical and Statistical Programmers and Regulatory Medical Writers.
• Functional contacts in J& J Innovative Medicine include but are not limited to Clinical Teams, Program Delivery Leaders, Trial Delivery Leaders, Trial Delivery Managers, Local Trial Managers, Site Managers, Clinical Risk Managers, and Biostatisticians.
• External contacts include but are not limited to External Service Providers.

Education and Experience Requirements:

Required

• Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Health Sciences or Data Sciences. Advanced degrees preferred (e.g., Masters, PhD).
• Approximately 6 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. In-depth knowledge of Central Monitoring and Risk-based Quality Management (RBQM)/Risk[1]Based Monitoring (RBM) concepts.
• In-depth knowledge of regulatory guidelines (e.g., ICH-GCP).
• Demonstrated understanding of advanced data analysis and basic statistical concepts.
• Project, risk, and team management experience and an established track record leading teams to successful outcomes.
• In-depth knowledge of technology platforms and system used for the collection, analysis and reporting of data
• Strong planning and coordination skills. Experience collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and external suppliers.
• Strong communication, leadership, influencing, and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing business environments.
• Excellent written and verbal communication skills (in English).
• Expert knowledge of clinical drug development processes