Senior Clinical Data Manager - Homebased

TFS Princeton , NJ 08540

Posted 3 days ago

TFS is a Global CRO headquartered in Sweden. We genuinely believe that Global in mind and local at heart is the core of our success. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.

The Senior Clinical Data Manager is part of the Global Biometrics Department within Clinical Development and will work operationally on preparing, conducting and completing Clinical Data Management tasks on assigned Study Teams, according to company policies, SOPs and regulatory requirements. This is a home-based position working for a TFS client, working with complex and large data.

Key responsibilities include:

  • Responsible for Clinical Data Management activities for assigned study
  • Act as Lead Clinical Data Manager for assigned data management projects
  • Act as a Project Lead for Biometric-only projects
  • Coordinate work of other Clinical Data Management staff assigned to the project
  • Review Study Protocol Develop CRF or review of sponsor-generated CRFs
  • Develop Database Define and program edit checks
  • Responsible to prepare, finalize and archive all related DM documentation
  • Develop Data Management Plan and Data Management Report
  • Develop Data Validation Plan (including definition of edit checks
  • Develop Data Entry Instructions/ eCRF completion guidelines Coordinate validation of database, edit checks and trial and site settings
  • Performs validation of database, edit checks and trial and site settings in studies
  • Perform CRF handling including logging, tracking and sorting
  • Support the CRAs in study related questions
  • Perform Data cleaning and query handling
  • Ensure completion of Quality Control task for the finalization and transfer of the study database and related documents to the sponsor
  • May coordinate SDTM mapping with the senior programmer when needed
  • Carry out all tasks related to database closure
  • Provide CDs with study documentation to the sites (patient data, audit trail and closed queries)
  • File/archive essential documents
  • Provide metrics and status updates to senior management and project leaders and sponsors if required
  • Train and support Clinical Data Associates and Clinical Data Managers
  • Train and support both internal and external Clinical Study Teams Represent TFS Data Management in sponsor and investigator meetings
  • Responsible to escalate any issues on projects or the need for potential SOP deviations
  • May perform system validation, create test scripts for system validation as well as perform UAT of ePROs in collaboration with the CRA, working with complex an

Requirements

  • 4 year Bachelors Degree, preferably in a relevant discipline
  • Minimum 5 years relevant data management experience
  • Proven data management skills
  • Excellent verbal and communication skills
  • Ability to deal effectively with sponsors and internal customers
  • Ability and willingness to travel on occasion

Benefits

A great place to work. You will also get the opportunity to be part of a team with highly intelligent and, passionate experts. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.

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Senior Clinical Data Manager - Homebased

TFS