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Associate, Clinical Trial Management

New Jersey All, NJ

Posted: 02/28/2019 Job Type: Clinical Job Number: JN -022019-23812
  • Responsible for performing tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations
  • Ensures the assigned clinical study is run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures
  • May participate as a Global Clinical Trial Representative in cross-functional teams such as Case Report Form Review Team and Clinical Trial Team
  • Responsible to support and work with the FACT team to conduct study feasibility; they are responsible for the initial assessment of any vendors, supplies planning and the development of study specific documents and timelines as required
  • Responsible for supporting document development including the informed consent forms; regional investigator meetings/presentation of materials; the development of regional enrollment initiatives; and planning regional clinical study supplies
  • Responsible in obtaining the required translations, collecting non-essential documents from site and ensuring sites are trained in collaboration with the site monitor
  • Responsible for supporting the following: study financial management; database lock activities; study drug management; trial master file management; study enrollment management (e.g. contingency plan execution); periodic review of protocol deviations; vendor management; and ensuring adverse event reporting
  • Responsible for supporting the following activities: database lock activities; ensuring all documents are filed in the TMF appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed
  • Other activities, special projects and assignments may be given as required
  • Bachelor s Degree; preferably in science or health-related field
  • 3+ years of Clinical Research experience from a pharmaceutical/CRO company
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