Clinical Data Manager Job at cGxPServe, Baltimore, MD

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  • cGxPServe
  • Baltimore, MD

Job Description

Responsibilities:
  • Independently identify, prioritize, and lead all CDM activities for assigned study.
  • Represent CDM function at internal/external team calls.
  • Communicate and able to provide CDM expertise for DM related activities.
  • Responsible for ensuring the following activities are setup and reviewed for quality, including but not limited to.
  • CDM study file setup and periodic DM reviews to ensure currency of the study file
  • Ensure proper versioning control in all DM documentation.
  • CRF design, review, finalization, modifications.
  • Database design, review (user acceptance testing/documentation), finalization, modifications.
  • Data Management Plan review, finalization, modifications.
  • Edit check specifications design, review, finalization, modifications.
  • Data transfer specifications review, finalization, modifications.
  • Ongoing manual data reviews and quality reviews of query process.
  • Appropriately communicate data issues and ensure full execution of resolution.
  • Data cleaning.
  • DM listings design, review, finalization, modifications.
  • Familiar with medical term coding using MedDRA, WHO Drug dictionaries.
  • Data reconciliation of SAEs between the CRF and safety database.
  • Data reconciliation of third-party vendor data between the CRF and third-party vendor data (e.g. key header reconciliation of lab data to CRF header data).
  • Understanding of internal, external data flows and ensure proper execution of data transfers per the Data Transfer Specifications.
  • EDC access requests management.
  • Ensure ongoing DM study metrics reporting is being communicated at team calls and outstanding items are actioned appropriately.
  • End to end experience in all phases of a clinical study from a DM perspective: startup, maintenance, closeout.
Requirements:
  • Bachelor's degree.
  • 5-7 years of increasing DM experience in Pharmaceutical or Biotech Clinical Data Management.
  • Proficient in computer technology used in an office environment (Microsoft Word, Excel, PowerPoint).
  • Knowledge of the clinical trial process, ICH GCP, and applicable health authority regulations.
  • Experience with Science 37 EDC platform is highly preferred but not limiting.
  • Experience with Medidata RAVE, SAS, and Coding tools.
  • Strong understanding of good clinical data management and documentation practices.
  • Strong attention to version and change control process.
  • Awareness and familiarity of statistical methodologies and outputting (e.g. TLFs).
  • Ability to solve complex problems in all areas of data management.
  • Strong DM project management skills
  • Effective and professional communication skills, both verbal and written
  • Ability to work independently in a remote environment and virtual setting
  • Strong attention to detail.

Job Tags

Remote job,

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