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Senior Clinical Data Manager

New Jersey All, NJ

Posted: 10/16/2019 Job Type: Clinical Job Number: JN -102019-25823

Job Description

  • Assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and apply Data
  • Management best practices
  • Accountable or a contributor for CDM deliverables from protocol creation until release of data for analysis
  • Ensure CDM input and contributions to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans)
  • Incorporates and maintains Medical Standards in clinical studies for all elements of the medical standards package
  • Documents all activities adequately for all assigned studies according to SOPs and takes a lead role in QC activities, which includes, but is not limited to: initiating the documentation, maintaining document management systems, coordinating and ensuring contributions from relevant functions, requesting a timely QC of the documentation, informing relevant functions of results and ensuring proper communication between functions, QC manager and self so that all issues are reconciled
  • Specifies and develops study specific eCRFs, data consistency checks based on Medical Standards, the Clinical Study Protocol and input from the study team
  • Prepares, tracks and implements standard plans (i.e., Project Plan, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management study set-up, conduct and closure activities
  • Accountable for data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of important deviations and validity findings, planning and conduct of interim and final Blind Review Meeting, preparation and completion of the final Blind Review Report
  • Engages actively in ongoing data review/reconciliation activities and utilizes dashboards, metrics and patient trackers to monitor data arrival and clean up
  • Shares data arrival and cleanup status and metrics with the Study Team
  • As applicable, plans and tracks data contributions of specialized functions typically used for early clinical development activities like Pharmacokinetics, Biomarker, Bioinformatics, Pharmacometrics, as well as strategic operational partners
  • As applicable, establishes data management best practices for data generated in relevant research activities which may be needed in later project activities like decision making processes and submissions; this includes but is not limited to the following: support of setting data standards compatible with development standards, support of central storage and inventory, supporting data transfer activities from external vendors, supporting integration with data generated in clinical phases of development
  • Supports study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions
  • Identifies and issue queries, incorporate query replies and track query status
  • Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards
  • Ensures complete, accurate and timely documentation for all projects/studies according to established SOPs

Required Qualifications:

  • Bachelor s degree is required
  • 5+ years of Clinical Data Management experience
  • 2 years of experience should demonstrate full responsibility as a Study Data Manager
  • Detail oriented individual with a sufficient knowledge of clinical research/development operations in order to execute relevant data management
  • activities independently
  • Lead a CDM team, and professionally contribute to project level activities
  • Ability to work effectively in a global environment
  • Significant experience in using data management methodologies



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