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

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, India

Job Description:

Position Summary:

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:

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.

Provide 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 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.

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

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 a 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 concept selected.

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Analyst Central Monitoring Manager