Job Description

Enabling Business Information Solutions (EBIS)Analyst, TMFPosition 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

• 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., CROs and FLEX resources), and External Vendors

• A minimum of a bachelors 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

• Primary Location: India
• Ability to travel up to 15% of time (Domestic/International) is required

Johnson & Johnson