Johnson & Johnson Hiring TMF Analyst in Mumbai, Bangalore, Hyderabad

Johnson & Johnson Hiring TMF Analyst in Mumbai, Bangalore, Hyderabad

Are you passionate about clinical trials and looking for an exciting opportunity with a global leader in the pharmaceutical industry? Johnson & Johnson is seeking a dedicated TMF Analyst to join their team in Mumbai, Bangalore, or Hyderabad. This role offers a chance to work with cutting-edge technology and contribute to impactful projects. Read on to learn more about the qualifications, responsibilities, and application process for this position.

Job Role Overview

Position: TMF Analyst, CoE
Locations: Mumbai, Bangalore, Hyderabad
Job Function: R&D Digital
Travel: Up to 15% (Domestic/International)

Key Responsibilities

As a TMF Analyst at Johnson & Johnson, you will play a critical role in ensuring system compliance and inspection readiness. Your primary responsibilities will include:

• Supporting TMF processes and functionality, including eTMF capabilities and document management.
• Working with stakeholders to enable TMF systems and reports to meet business needs.
• Managing TMF content management processes, quality, and metrics oversight.
• Supporting end-user compliance for ongoing inspection readiness.
• Establishing study-specific TMF structures and managing system integrations.
• Providing TMF filing and data support to optimize TMF quality and standardization through automation.

Essential Qualifications

To be successful in this role, candidates should possess the following qualifications:

• A minimum of a bachelor’s degree, preferably in health, science, or information technology.
• At least 3 years of relevant experience in the pharmaceutical industry or clinical trials.
• Experience with electronic records or electronic Trial Master File (eTMF).
• Proven ability to develop quality and trending metrics.
• Strong technical and analytical expertise.
• Experience with audit and inspections, robotic process automation, machine learning, or artificial intelligence is preferred.

Responsibilities in Detail

• Understand Clinical Trial processes in order to identify opportunities to automate or streamline EBIS business processes and system functionality.
• Contribute in system releases including testing and system improvements.
• Contribute in and/or support Audits/Inspections as needed.
• Support CAPA management activities
• Support TMF business user questions within the applicable solution and in collaboration with the technical support team.
• Work independently or as a part of a team under general supervision.
• Responsible for ensuring compliance to TMF related SOPs, WI, regulations.
• Partner with IT, and system owners (oneCTMS, iAware, VIPER, , etc.) to maintain system integrations, DSSI and resolve integration related issues
•  Form productive relationships with internal and external business partners by listening, clarifying and responding effectively.
• Provide end to end TMF support and expertise to cross-functional TMF stakeholders in alignment with TMF management process, TMF Content Map and compliance requirements
• Provide TMF Quality and Metrics Oversight and Trending to Stakeholders, and management
• Design, Develop, Implement TMF Quality and Oversight report and metrics/visualizations
• Provide end to end TMF support and expertise to cross-functional TMF stakeholders in alignment with TMF management process, TMF Content Map and compliance requirements
• Drive continuous improvement to TMF processes, metrics, TMF system, to drive TMF inspection Readiness and support related change management in accordance with the industrial standards
• Responsible for providing central TMF filing and data management support to stakeholders through automation
• Work with TMF COE management team and other team members to locate and identify areas yielding highest efficiency-continued business improvement
• Support TMF Business Operations team in addressing business user questions and onboarding new functional areas, groups (e.g.: CRO, external partners, site staff) and departments, training
  • Support any other tasks as relevant to TMF

Working Relationships

• Reporting To: TMF CoE Manager
• Internal Interfaces: GCDO, EBIS, Functional Areas, IT, Study Teams
• External Interfaces: CROs, External Vendors, and Partners

Application Process

If you are interested in this exciting opportunity, apply online through the Johnson & Johnson career portal: Apply Here