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Analytical Monitor – Clinical Data Analytics (CDM) Job At J&J

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Johnson & Johnson,

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences, Ph.D, Data Sciences, health Sciences

Penjerla, Telangana (Hybrid)

2-5 years

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Are you passionate about advancing healthcare through data analytics? Johnson & Johnson, a global leader in innovative medicine, is seeking a talented Analyst II Analytical Monitor to join its Integrated Data Analytics and Reporting (IDAR) team in Penjerla, Telangana. This hybrid role offers a unique opportunity to support clinical trials by leveraging cutting-edge data analytics, ensuring data reliability, and enhancing site performance. If you have a background in health sciences, data sciences, or clinical trial operations, this position is your chance to make a meaningful impact on global health. Apply by August 15, 2025, and be part of a team driving the future of healthcare innovation.

Key Responsibilities

As an Analyst II Analytical Monitor, you will play a pivotal role in ensuring the success of clinical trials through advanced data analytics and risk-based monitoring. Your responsibilities will include:

  • Conducting analytical monitoring activities for multiple clinical trials, ensuring compliance with Johnson & Johnson’s Standard Operating Procedures (SOPs) and regulatory guidelines like ICH-GCP.
  • Performing fit-for-purpose reviews at site and subject levels to detect issues early and prevent recurrence.
  • Collaborating with Site Managers and Central Monitoring Managers to address trends and signals affecting data quality and study participant safety.
  • Accessing various systems and databases to identify risks related to site and subject-level data quality and compliance.
  • Providing timely analytical data insights to support Site Managers in prioritizing site engagement.
  • Supporting process improvement projects, including requirements development, user acceptance testing, and identifying enhancements for analytical tools.
  • Facilitating effective communication across cross-functional teams and managing escalation pathways as needed.

Qualifications

To excel in this role, candidates should meet the following requirements:

  • Education: Bachelor’s degree (BS/BA) in Health Sciences, Data Sciences, or a related field. Advanced degrees (Masters, PhD) are preferred.
  • Experience: Prior experience in the pharmaceutical, CRO, or biotech industry, with knowledge of clinical trial operations and study execution.
  • Technical Skills: Familiarity with data analysis, basic statistical concepts, and technology platforms for data collection, analysis, and reporting.
  • Regulatory Knowledge: Working knowledge of regulatory guidelines, such as ICH-GCP.
  • Soft Skills: Strong critical thinking, problem-solving, and communication skills (written and verbal in English). Ability to collaborate effectively in a cross-functional environment.
  • Preferred Skills:
    • Experience with complex data structures, statistical analysis, data modeling, or data visualization.
    • Knowledge of Risk-Based Quality Management (RBQM), Risk-Based Monitoring (RBM), or Quality by Design (QbD) concepts.
    • Familiarity with external data (e.g., Safety Lab, PK, Simple Biomarkers, ECG).

Benefits of Working at Johnson & Johnson

Joining Johnson & Johnson offers a range of benefits designed to support your professional and personal growth:

  • Innovative Environment: Work with cutting-edge technology and data analytics to drive healthcare breakthroughs.
  • Hybrid Work Model: Enjoy the flexibility of a hybrid role, combining remote work with collaboration at our Penjerla facility.
  • Career Growth: Access opportunities for professional development and involvement in process improvement projects.
  • Global Impact: Contribute to clinical trials that shape the future of healthcare worldwide.
  • Collaborative Culture: Work alongside experts in Innovative Medicine and MedTech, fostering meaningful partnerships.

How to Apply

Application Link

Analytical Monitor - Clinical Data Analytics (CDM) Job At J&J

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The PharmaBharat Editorial Team, comprised of pharmaceutical industry experts with over 3 years of collective experience in research, regulatory affairs, and market analysis, delivers accurate and timely updates on trends, innovations, and career opportunities. Our content is rigorously vetted by professionals with advanced degrees in pharmacy and biotechnology, ensuring authoritative and trustworthy insights for job seekers in the pharmaceutical sector.