Sr. Analytical Monitor - Hyderabad

Integrated Data Analytics and Reporting (IDAR)

Sr. Analytical Monitor

Position Summary:

The Senior Analytical Monitor is an experienced individual contributor with strong 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 Senior Analytical Monitor is accountable for executing processes and activities for multiple clinical trials in conformance to all relevant laws, regulations, guidelines, policies, and procedures. They typically work with minimal direction from their functional manager.

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 and 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 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 for multiple trials, often of higher complexity.

• 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.

• Uses various systems, databases and reporting tools to identify potential risks related to 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).

• Approximately 8-12+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.

• Knowledge of trial site operations and study execution

• Strong knowledge of regulatory guidelines (e.g., ICH-GCP).

• Demonstrated strong understanding of data analysis and familiarity with basic statistical concepts and hands-on experience using data visualization tools

• Project, Issue, and risk management experience with strong ability to apply critical thinking & problem-solving skills, to drive solutions &helping to lead teams to successful outcomes.

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

• Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional

• Planning and coordination skills. Experience working with cross-functional stakeholders and leading teams in a matrix environment and partnering with/managing stakeholders.

• Strong leadership and communication skills (written and verbal). Ability to influence stakeholders.

• Excellent written and verbal communication skills (in English)

• Strong 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.

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