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.
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Johnson & Johnson Hiring TMF Analyst in Mumbai, Bangalore, Hyderabad[/caption]
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
https://pharmastuff.org.in/job/johnson-johnson-hiring-tmf-analyst
