Analyst, Trial Master File (TMF) Job

Job description

Johnson & Johnson companies are equal opportunity employers. Analyst, Trial Master File (TMF)-3185151207DescriptionJanssen Pharmaceuticals, Inc., a division of Johnson & Johnson's Family of Companies is recruiting for a Analyst, Trial Master File (TMF) with primary location in Raritan, NJ with consideration of other locations Titusville, NJ and Spring House, PAAt the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
The Analysts' responsibilities include providing TMF support for assigned clinical trials and management of electronic TMF records. This individual will be working with study teams and individual TMF owners to establish study-specific TMF structure and to ensure quality of TMF and TMF content, according to the established processes. He/she will be collaborating across user community to promote TMF quality. The Analyst will be monitoring the quality and completeness state of the assigned study TMFs.
The Analyst will assist in the development and monitoring of metrics as they pertain to the overall TMF completeness process that will allow for real-time data and visibility into the state of the TMF. This individual will collaborate with Global Trial Managers, Local Trial Managers and Functional Area representatives regarding Binder Review. He/she will use the V-TMF reporting tool to monitor TMF completeness and supports the user community in the use of the reporting tool. The Analyst will partner with CTMS team to align on Study/Country/Site build as well as general support. This individual will be responsible for working with various teams in supporting the management of TMF documents and maintaining inspection readiness and submission readiness within the V
- TMF system. He/she will work with Lead TMF Analyst and TMF Compliance Specialist to locate and identify areas yielding highest efficiency. Responsible for study lock/unlock. The Analyst will support Audits/Inspections. This individual will work with users to identify and manage study expected document lists (EDL). Provides system demonstrations to TMF Content Owners as needed. This individual will be responsible for supporting TMF business user questions.
QualificationsA minimum of a Bachelor’s degree is required. A focused degree in health, science or information technology is preferred. A minimum of 4 years relevant experience is required. Pharmaceutical and/or clinical trial experience is preferred. Experience directly involved with the collection and creation of a variety of TMF content and knowledge of the complete clinical trial conduct process is preferred. Good understanding of the drug development process including ICH/GCP and local regulatory requirements is preferred. Experience in database administration and strong knowledge of electronic documents is required.
This role will also require the ability to provide general business oriented assistance, with a superior communication, problem solving and prioritization skills. The individual must be self-motivated with a track record of demonstrated aptitude in working in a team-driven environment. Must have the ability to maintain and improve consistent and sound business processes in a dynamic, cross-cultural environment required.
This position’s primary location will be in Raritan, NJ with consideration of other locations in Titusville, NJ or Spring House, PA and may require up to 10% travel.
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J2W: LI NAPrimary Location:North America-United States-New Jersey-RaritanOther Locations:North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring HouseOrganization: Janssen Research & Development, LLC. (6084)Job Function: Clinical Data ManagementTravel:Yes, 10 % of the TimeCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement