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 set up and reviewed for quality, including but not limited. 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. Katalyst Healthcares and Life Sciences
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