Job Description

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 https://www.jnj.com
Job Function: Data Analytics & Computational Sciences
Job Sub Function: Clinical Data Management
Job Category: Professional
All Job Posting Locations: PENJERLA, Telangana, India
:
Integrated Data Analytics and Reporting (IDAR)
Analyst II Analytical Monitor
Position Summary:
The Analyst II Analytical Monitor is an individual contributor with knowledge of site monitoring and Analytical Risk Based Monitoring (ARBM) practices, data analytics, methods, processes, and technologies.
Empowered by technology, optimized processes and targeted data analytics, Analytical Monitors will enable Site Managers to dedicate a greater proportion of their time for meaningful engagement with sites, driving improved performance, data reliability and site satisfaction.
The Analyst II Analytical Monitor supports execution of processes and activities for multiple clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures. This position receives ongoing direction from their functional manager and/or other experts to achieve objectives.
This position collaborates closely with Site Managers, other Data Management & Central Monitoring roles, & other internal partner functions and/or external service providers to achieve successful, cooperative partnerships.
Principal Responsibilities:

• Conducts activities in compliance with J&J functional SOPs, processes and policies.
• May support 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.
• Facilitates smooth and effective communication, managing multiple communication streams. 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 in J&J Innovative Medicine include but are not limited to Site Managers and Local Trial Managers.
• Functional contacts within IDAR include but are not limited to Functional Leadership, Central Monitoring, Data Management, Data Acquisition Experts, Clinical Programmers.
• 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).
• Experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
• Knowledge of trial site operations and study execution
• Working knowledge of regulatory guidelines (e.g., ICH-GCP).
• Demonstrated understanding of data analysis and familiarity with basic statistical concepts.
• Project, Issue, and risk management experience with ability to apply critical thinking & problem-solving skills, to drive solutions & helping to lead teams to successful outcomes.
• Experience working with technology platforms and systems used for the collection, analysis and reporting of data.
• Ability to effectively collaborate in an environment of cross-functional stakeholders, plan and coordinate tasks effectively.
• Strong ability to communicate effectively (written and verbal).
• Good written and verbal communications skills (in English).
• Knowledge of clinical drug development processes.

Preferred Experience

• Working with complex data structures and reporting specifications
• Working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG, or similar.
• Possess proficiency in statistical analysis, data modelling, and data visualization techniques, or demonstrate strong knowledge in these areas.
• Knowledge of Risk-based Quality Management (RBQM)/Risk-Based Monitoring (RBM) / Quality by Design (QbD) concepts