Clinical Data Manager jobs in Perth Amboy, NJ

Clinical Data Manager manages all aspects of clinical database design and reporting. Establishes and maintains policies and procedures for gathering, analyzing, and reporting clinical data. Being a Clinical Data Manager standardizes data management procedures and documents departmental operating procedures. May require an advanced degree. Additionally, Clinical Data Manager typically reports to a manager or head of a unit/department. The Clinical Data Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Clinical Data Manager typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Clinical Data Manager
  • Evolution Research Group
  • New Providence, NJ FULL_TIME
  • Job Title: Clinical Data Manager

    Location: Remote

    Job Description:

    The Clinical Data Manager is responsible for oversight and conducting data activities in an efficient manner and in accordance with all SOPs and regulations. Responsibilities include all data management activities, customer relationship management, development and implementation of the data correction process, discrepancy resolution, data control activities, and data validation. In addition to these standard clinical data management responsibilities, the Senior Clinical Data Manager will also assist the management team with SOP review & update, process improvement, employee onboarding, and training.

    Essential Duties and Responsibilities:

    • May be designated Lead Data Manager on assigned study, working under oversight of Data Management Team Lead or other Senior Data Manager.
    • Either as the Lead Data Manager, or assisting designated Lead Data Manager, drive all assigned study data management activities, from study startup through closeout in accordance with SOPs.
    • Draft & final protocol review, study specification creation, case report form design, database design/build, form and edit check programming within EDC, and review of all data management specific study documents.
    • Implementation of all data cleaning processes, discrepancy resolution, data transfer/control activities, and validation.
    • Proactively and independently manages data management activities on assigned studies, including but not limited to setting and management of timelines, milestone deliverables, etc.
    • Lead and/or coordinate the user acceptance testing through the build phase of the EDC platform to ensure completeness and correctness.
    • Develop and implement the Data Management Plan which outlines the end-to-end handling of the data correction process, discrepancy resolution, data control activities, and data validation.
    • Direct clinical trial studies from the initial preparation through database closeout, including all necessary regulatory submissions by standardizing study data in compliance with established guidelines.
    • Ensure all Data Management study documentation and management of clinical study data is in accordance with ICH/GCP, SOPs, and regulations.
    • Proactively coordinate and perform start-up, processing, and finalization activities as detailed in Lotus SOPs and the Data Management Plan.
    • Proactively drive/support departmental process improvement efforts to include regular SOP, work instruction, and master document review/update.
    • Assist other Clinical Data Managers with delivery of data management activities on an ad hoc basis.
    • Ensure documentation and management of clinical study data is in accordance with regulations.
    • Proactively coordinate and perform start-up, conduct, and closeout activities as detailed within SOPs.
    • Ensure the project quality through direct supervision and Quality Control of team members’ work. Provide feedback as needed to team members to ensure the submitted work meets sponsor expectations.
    • Participate as needed in reviewing and responding to QA audit reports.
    • Actively participate in appropriate sponsor/project team meetings to provide clear and concise information as to how the study is progressing from a Data Management perspective including clearly articulating any issues or patterns observed throughout the study.
    • Proactively manage timelines and projections.
    • Proactively manages project quality through supervision and Quality Control of assigned team members’ work.
    • Participate in reviewing and responding to QA audit reports.
    • Proactively participate in appropriate sponsor/project team meetings.
    • Leads and/or participate in User Acceptance Testing for projects as needed.
    • Active involvement in departmental and organizational meetings and initiatives.
    • Lead or assist with development and documentation of department procedures.
    • Lead or participate in the review of cross functional department procedures.
    • Train and mentor newer team members in accordance with the established departmental procedures and SOPs.
    • Communicate with cross functional groups throughout the project lifecycle. Monitor project scope.
    • Maintain key vendor relationships such as EDC System Vendor, etc.
    • Perform other miscellaneous related duties, as required.

    Education and/or Experience:

    • MS/MA in health science, life science, information technology, or nursing AND 5 years equivalent experience OR demonstrated aptitude for the Clinical Data Manager role.
    • Experience working in CRO industry preferred.
    • Working knowledge of EDC studies.

    Skills and Abilities:

    • Excellent organizational skills.
    • Strong written and verbal communication skills.
    • Exceptional attention to detail.
    • Technology proficiency including Data Management Systems.
    • Study documentation production and maintenance, data processing, data review.
    • Knowledge of clinical research including regulatory requirement GCP/ICH Data Quality.
    • Strong interpersonal skills.
    • Strong computer skills, including Microsoft Office.
  • 20 Days Ago

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Clinical Data Transformation Manager
  • Katalyst Healthcares & Life Sciences
  • South Plainfield, NJ FULL_TIME
  • Title: Clinical Data Transformation Manager, Basking Ridge NJ or Armonk NY (Onsite) Summary: This role serves as the Clinical Data Transformation Manager to create an automated, scalable approach for ...
  • 1 Day Ago

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Nurse Manager Women's Services
  • Clinical Management Consultants
  • Red Bank, NJ FULL_TIME
  • Join the Prestigious Women's Services Team as a Nurse Manager - Maternal Child Health at this incredible award winning hospital in Vibrant New Jersey. Imagine being part of a dynamic unit where you ca...
  • 19 Days Ago

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RN Manager Surgery
  • Clinical Management Consultants
  • Shrewsbury, NJ FULL_TIME
  • Are you a seasoned nursing professional ready to take the next step in your career? Join this esteemed Magnet Designated facility in the heart of Central New Jersey as a Nurse Manager OR, where excell...
  • 1 Day Ago

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Clinical Data Analyst
  • Paradigminfotech
  • Edison, NJ FULL_TIME
  • Company DescriptionParadigm Infotech. Inc is a global IT solutions provider focused on delivering customer value through high Quality Processes and Cost-efficient solutions. Paradigm has been one of t...
  • 11 Days Ago

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Senior Clinical Data Analyst
  • HMH HOSPITALS CORPORATION
  • Edison, NJ FULL_TIME
  • Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in c...
  • 1 Month Ago

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0 Clinical Data Manager jobs found in Perth Amboy, NJ area

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Senior Clinical Programmer Analyst (100% Remote role)
  • Maxis Clinical Sciences
  • Nutley, NJ
  • Job Description Job Description SAS Programmer Analyst Can be 100% remote We need someone with SAS programming skills wi...
  • 3/28/2024 12:00:00 AM

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Senior Computer Systems Validation Analyst
  • Maxis Clinical Sciences
  • Edison, NJ
  • Job Description Job Description Review of URS document and understand the functionality Responsible for all the validati...
  • 3/27/2024 12:00:00 AM

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Senior Clinical Data Manager (Hybrid)
  • Genmab A/S
  • Princeton, NJ
  • At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneeri...
  • 3/27/2024 12:00:00 AM

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Contractor - Senior Clinical Data Manager (Hybrid or Remote)
  • Genmab A/S
  • Princeton, NJ
  • At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneeri...
  • 3/27/2024 12:00:00 AM

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Business Development Manager, Life Sciences, Clinical Platform
  • Tephra
  • Edison, NJ
  • Description: Job Title: Business Development Manager Life Sciences Clinical Platforms, NA Location: New Jersey, USA Job ...
  • 3/27/2024 12:00:00 AM

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Clinical Database Programmer/EDC/Medidata Rave -REMOTE
  • Maxis Clinical Sciences
  • Nutley, NJ
  • Job Description Job Description Remote Qualifications •relevant work experience to include data management and/or databa...
  • 3/27/2024 12:00:00 AM

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Clinical Data Associate
  • Anavex
  • New York, NY
  • Anavex Life Sciences Corp. is seeking a Clinical Data Associate that will support the team on clinical trial study desig...
  • 3/26/2024 12:00:00 AM

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Senior Clinical RAVE Programmer Analyst - FULLY HOME BASED
  • Maxis Clinical Sciences
  • Nutley, NJ
  • Job Description Job Description Qualifications • Minimum 10 years of relevant work experience to include data management...
  • 3/26/2024 12:00:00 AM

Perth Amboy is a city in Middlesex County, New Jersey, United States. The City of Perth Amboy is part of the New York metropolitan area. As of the 2010 United States Census, the city's population was 50,814, reflecting an increase of 3,511 (+7.4%) from the 47,303 counted in the 2000 Census, which had in turn increased by 5,336 (+12.7%) from the 41,967 counted in the 1990 Census. Perth Amboy has a Hispanic majority population. In the 2010 census, persons of "Hispanic, Latino or Spanish origin" made up 78.1% of the population, second to Union City at 84.7%. Perth Amboy is known as the "City by t...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Data Manager jobs
$125,779 to $156,595
Perth Amboy, New Jersey area prices
were up 1.5% from a year ago

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