Analyst Central Monitoring Expert HyderabadBangaloreMumbai

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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Analyst Central Monitoring Expert - Hyderabad/Bangalore/Mumbai

The Analyst Central Monitoring Expert 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 Analyst Central Monitoring Expert supports central monitoring processes and ARBM activities for multiple clinical trials and may work in combination with other Central Monitoring Experts.

The Analyst Central Monitoring Expert 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. This position may be specialized into the following roles based on business needs: Central Monitoring Manager or Analytical Monitor.

Central Monitoring Manager Role-Specific Responsibilities:

Contributes to the ongoing development of the clinical trial ARBM model and related processes.

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

Provides input into the completion of ARBM related study start-up processes such as the protocol assessment protocol de-risking integrated risk management plan creation ARBM- related input into the monitoring guidelines and the creation of targeted source data verification/review specifications.

Analyzes data from available reporting mechanisms and dashboards and supports identification of potential risks for reporting out at the Central Monitoring Working Group (CMWG).

Documents relevant potential risks and works with team to ensure adequate documentation of resolution. Supports ARBM strategies and participates in the cross-functional CMWG. May support the identification of Critical to Quality (CtQ) factors and contribute to the development of Study-Specific Reports (SSRs). May train Analytical Monitors on study specific analytic review requirements.

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.

Education and Experience Requirements:

Required

Bachelors 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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Preferred Skills: