Analyst, Analytical Monitor - Bangalore / Hyderabad / Mumbai

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Analyst, Analytical Monitor - Bangalore / Hyderabad / Mumbai

Position Summary: 

The Analyst, Analytical Monitor is an individual contributor role at entry level that supports the execution of analytical monitoring activities.  

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, 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. 

Principal Responsibilities:  

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

• Facilitates smooth and effective communication, managing multiple communication streams. Follows agreed escalation pathways where needed. 

• 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.  

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 Suppliers.

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.  

  • 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 

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