Lead Clinical Data Manager

Katalyst Healthcares & Life Sciences
ISelin, NJ Contractor
POSTED ON 12/3/2022 CLOSED ON 2/9/2023

Job Posting for Lead Clinical Data Manager at Katalyst Healthcares & Life Sciences

Responsibilities:
  • Be accountable for CDM deliverables from protocol review to database closure and oversee production of SDTM dataset s.
  • Translating clinical protocols into electronic case report forms and developing the associated edit check specifications, in addition to a data review plan.
  • Responsible for contributing to vendor selection and management, assume operational and/or oversight responsibility as Lead Clinical Data Manager for outsourced studies.
  • Ability to understand and develop specifications or Data Transfer Agreements with external vendors ( e.g. IxRS , PK, Biomarker or Imaging groups) .
  • Coordinate data transfer activities from external vendors.
  • Adhere to and develop Standards related to eCRFs, edit checks other packages related to CDM deliverables.
  • Document all activities adequately for assigned studies according to Standard Operating Procedures (SOPs) by initiating, maintaining, and archiving documents to be always audit/inspection ready.
  • Be able to develop or review plans associated with the CDM function (i.e., Project Plan/Timelines, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management activities.
Requirements:
  • Minimum of bachelor's degree in natural or physical sciences, health or Informatics related areas, Master's degree in the above fields preferred.
  • Sufficient knowledge of clinical research operations to execute relevant data management activities independently.
  • At least 3 years of study level experience as a Data Manager in leading roles.
  • Good understanding of the drug development process.
  • Strong organizational skills and able to collaborate with minimal supervision.
  • Oncology background, specifically, RECIST 1.1 preferred.
  • Basic SAS, R, SQL or other programming knowledge preferred.
  • Experience in using database and database tools and knowledge of data privacy and GDPR.
  • Proven ability to run multiple concurrent studies and manage CROs in meeting deliverables on time and quality.
  • Good project management skills and the use of PM tools ( e.g. MS Project) .
  • Ability to prioritize task, identify, and mitigate risks concerning timelines Data Quality.




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