Analytical Monitor I

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. Learn more at jnj.com.

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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.

Learn more at https://www.jnj.com/innovative-medicine

The Analytical Monitor is an individual contributor role at entry level that supports the execution of central monitoring and Analytical Risk-Based Monitoring (ARBM) activities for clinical trials in conformance to all relevant laws, regulations, guidelines, policies and procedures.

The Analytical Monitor supports central monitoring processes and ARBM activities for multiple clinical trials and may work in combination with other Analytical Monitors.

The Analytical Monitor may provide input into central monitoring and ARBM-related recommendations and decisions for specific trials or assignments that can have an impact on study processes and oversight of study participant safety and data quality. This position receives ongoing direction from their functional manager, Central Monitoring Leader, and/or other Central Monitoring Experts to achieve objectives.

Principal Responsibilities:

•            Conducts activities in compliance with J&J and Central Monitoring SOPs, processes and policies.

•            May support innovation or process improvement projects which may include but are not limited to participation in requirements development, user acceptance testing and identification of improvements to existing and new analytical tools.

•            Facilitates smooth and effective communication, managing multiple communication streams and influencing key cross functional stakeholders. Follows agreed escalation pathways where needed.

Analytical Monitor Role-Specific Responsibilities:

- Performs analytical monitoring activities for clinical trials within assigned scope of responsibility in line with portfolio timelines and priorities, including support of execution and close-out as outlined in the end-to-end process.

- Analytical Monitors will conduct regular (fit for purpose) reviews at site and subject level that will help early detection of issues, and prevent recurrence

- Collaborates closely with the Site Manager and Central Monitoring Manager to action trends and signals detected at the site and subject level.

- Accesses various systems, databases and reporting tools to identify potential risks related to the site and subject level data quality, study participant safety and compliance by identifying trends and early warning signals

- Provides timely analytical data insights to support the Site Managers in making decisions on site prioritization and critical engagement.

Principal Relationships:

•            Functional contacts within IDAR include but are not limited to Data Management & Central Monitoring: Data Management Leaders (DML), Global Data Managers (GDM), Clinical Data Managers (CDM), Data Acquisition Experts (DAE), and Clinical Programmers (CP), Therapeutic Area Experts (TAE) and Statistical Programmers.

•            Functional contacts in J&J Innovative Medicine include but are not limited to Study Responsible Physicians, Study Responsible Scientists, Trial Delivery Lead, Trial Delivery Managers, Local Trial Managers, Site Managers, Clinical Risk Managers, and Biostatisticians.

•            External contacts include but are not limited to External Suppliers.

Required

•            Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Health Sciences or Data Sciences.

•            Experience with data analysis.

•            Experience working with technology platforms and systems used for the collection, analysis and reporting of data.

•            Ability to collaborate in an environment of cross-functional stakeholders, plan and coordinate tasks effectively.

•            Ability to communicate effectively in English (written and verbal).

Preferred

•            Knowledge of clinical drug development within the pharmaceutical industry or related industry

•            Familiarity with basic risk management, project management, and/or statistical concepts

•            Knowledge of Central Monitoring and Risk-based Quality Management (RBQM)/Risk-based Monitoring (RBM)/Quality by Design (QbD) concepts