Job Information
J&J Family of Companies TMF Analyst - Mumbai/Bangalore/Hyderabad in Karnataka, India
TMF Analyst - Mumbai/Bangalore/Hyderabad - 2406220769W
Description
Enabling Business Information Solutions (EBIS)
Analyst, TMF
Position Summary:
The Analyst TMF CoE is an integral role within TMF COE that will serve as an interface between stakeholders, system and processes to drive overall system compliance and inspection readiness. He/she will have the responsibility to support TMF process and functionality including but not limited to, capabilities of eTMF, Study Start Up and Document to cross-functional TMF stakeholders. This includes working with stakeholders to enable the TMF system and reports via innovative solutions to meet business needs, TMF content management process improvisation, TMF Quality and Metrics oversight, Change Management, defining, implementing and continually improving TMF quality processes and oversight metrics, support end user compliance for ongoing Inspection Readiness. Working with Business Partners, including study teams and individual TMF owners, EBIS, and IT. He/she will be responsible to establish study-specific TMF structure, manage system integrations, support inspections and audits, according to the established processes. Provide TMF filing and Data support to optimize TMF quality and standardization through automation and TMF expertise. This role will utilize systems, reports and dashboards to identify trends, report out metrics and develop supporting tools and resources for the TMF End Users.
Principal Responsibilities:
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
Principal Relationships:
Reports to TMF CoE Manager
Internal Interfaces: GCDO, EBIS, TMF COE, Functional Areas, TAs, EBIS partners, IT, and Study Teams-ad hoc
External Interfaces: External partners and suppliers as necessary (e.g., CRO’s and FLEX resources), and External Vendors
Qualifications
Education and Experience Requirements:
A minimum of a bachelor’s degree is required. A degree in health, science or information technology is preferred
A minimum of 3 years of relevant Pharmaceutical industry and/or clinical trial experience is required
The ability to build and enhance Quality and Trending metrics that enable stakeholders to gain meaningful insights and take appropriate action is required
The ability to work with systems to develop meaningful innovative solutions, and cross interface is required
Experience working with electronic records, and/or electronic Trial Master File is strongly preferred
Experience leading and working with global cross functional technical/business teams is required
Ability to provide general business-oriented assistance is required
Superior communication, problem solving, and prioritization skills is required
Ability to maintain and improve consistent and sound business processes in a dynamic, cross-cultural environment is required
Experience with audit and inspections is preferred
Experience with Robotic Process Automation, Machine Learning, Artificial Intelligence is preferred
Experience directly involved with the collection and creation of a variety of TMF content; knowledge of the complete clinical trial conducts process; the drug development process including ICH/GCP and local regulatory requirements is preferred
Experience in database administration and/or the familiarity of electronic documents is preferred
Experience working with multiple IT systems, reporting tool, data warehouse is strongly preferred
Strong technical and analytical expertise is preferred
Other:
Primary Location: India
Ability to travel up to 15% of time (Domestic/International) is required
Primary Location Asia Pacific-India-Maharashtra-Mumbai
Other Locations Asia Pacific-India-Andhra Pradesh-Hyderabad, Asia Pacific-India-Karnataka-Bangalore, Asia Pacific-India-Delhi-Delhi
Organization Johnson & Johnson Private Limited (8080)
Job Function R&D Digital
Req ID: 2406220769W