J&J Family of Companies
Senior Clinical Data Manager
J&J Family of Companies, Honolulu, Hawaii, United States, 96814
J&J Family of Companies - Senior Clinical Data Manager - Honolulu, Hawaii
Senior Clinical Data Manager - 2406217367WDescriptionJohnson and Johnson is currently seeking a
Senior Clinical Data Manager
located in Titusville, NJ; Raritan, NJ; OR Spring House, PA. Remote work options in the United States may be considered on a case-by-case basis and if approved by the company.The Senior Clinical Data Manager provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity trials. The Senior Clinical Data Manager makes recommendations and decisions that have an impact on processes, timing, and structure for trials and assignments with minimal direction from manager or Data Management Leader (DML).Primary responsibilities:Take a leadership role with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations for assigned trial(s).Gather and/or review content and integration requirements for eCRF and other data collection tools.Establish conventions and quality expectations for clinical data.Set timelines and follow-up regularly to monitor delivery of all data management milestones.Ensure accurate review of related clinical data management documents as well as compliance with regulatory guidelines and documentation requirements.Ensure real-time inspection readiness of all DM deliverables for the trial; participate in Regulatory Agency and J&J internal audits as necessary.Lead the planning and tracking of content, format, quality, and timing of applicable data management deliverables.Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.Identify and participate in process, system, and tool improvement initiatives.Perform (complex) scientific study data review and management of CDM, Study Responsible Scientist (SRS), and Study Responsible Physician related queries in EDC system.Take a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.QualificationsEducation:Master’s degree or PhD preferred.Required:4 years experience in Pharmaceutical, CRO, Biotech, or Health related field or industry.Experience in clinical drug development within the pharmaceutical or related industry.Experience in clinical data review and knowledge of medical terminology.Strong written and verbal communication skills.Team leadership experience (direct line management not required).Strong clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols.In-depth knowledge of current clinical drug development processes.Knowledge of applicable international guidelines regarding data management of clinical trials.Knowledge of current industry standard (i.e., CDISC, SDTM, CDASH, etc.).Travel:
10% travel (domestic & international).Compensation:
The anticipated base pay range for this position in the US is $105,000 to $169,050. The anticipated base pay range for this position in San Francisco Bay Area is $121,000 to $194,350.This job posting is anticipated to close on October 18, 2024. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
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Senior Clinical Data Manager - 2406217367WDescriptionJohnson and Johnson is currently seeking a
Senior Clinical Data Manager
located in Titusville, NJ; Raritan, NJ; OR Spring House, PA. Remote work options in the United States may be considered on a case-by-case basis and if approved by the company.The Senior Clinical Data Manager provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity trials. The Senior Clinical Data Manager makes recommendations and decisions that have an impact on processes, timing, and structure for trials and assignments with minimal direction from manager or Data Management Leader (DML).Primary responsibilities:Take a leadership role with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations for assigned trial(s).Gather and/or review content and integration requirements for eCRF and other data collection tools.Establish conventions and quality expectations for clinical data.Set timelines and follow-up regularly to monitor delivery of all data management milestones.Ensure accurate review of related clinical data management documents as well as compliance with regulatory guidelines and documentation requirements.Ensure real-time inspection readiness of all DM deliverables for the trial; participate in Regulatory Agency and J&J internal audits as necessary.Lead the planning and tracking of content, format, quality, and timing of applicable data management deliverables.Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.Identify and participate in process, system, and tool improvement initiatives.Perform (complex) scientific study data review and management of CDM, Study Responsible Scientist (SRS), and Study Responsible Physician related queries in EDC system.Take a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.QualificationsEducation:Master’s degree or PhD preferred.Required:4 years experience in Pharmaceutical, CRO, Biotech, or Health related field or industry.Experience in clinical drug development within the pharmaceutical or related industry.Experience in clinical data review and knowledge of medical terminology.Strong written and verbal communication skills.Team leadership experience (direct line management not required).Strong clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols.In-depth knowledge of current clinical drug development processes.Knowledge of applicable international guidelines regarding data management of clinical trials.Knowledge of current industry standard (i.e., CDISC, SDTM, CDASH, etc.).Travel:
10% travel (domestic & international).Compensation:
The anticipated base pay range for this position in the US is $105,000 to $169,050. The anticipated base pay range for this position in San Francisco Bay Area is $121,000 to $194,350.This job posting is anticipated to close on October 18, 2024. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
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