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.
Hourly Wage Estimation for Lead Clinical Data Manager in ISelin, NJ
$62.85 to $82.55
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