Analyst Clinical Data Management Full Time

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Data Analytics & Computational Sciences

Job Sub Function

Clinical Data Management

Job Category

Professional

All Job Posting Locations:

Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India

Job Description

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

• 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

Required Skills

Preferred Skills:

Advanced Analytics, Analytical Reasoning, Biostatistics, Business Behavior, Clinical Data Management, Clinical Operations, Cross-Functional Collaboration, Database Applications, Data Privacy Standards, Data Savvy, Execution Focus, Good Clinical Practice (GCP), Process Oriented, Project Support, Report Writing, Standard Operating Procedure (SOP)