Demo

Clinical Data Management

Katalyst Healthcares & Life Sciences
Emeryville, CA Full Time
POSTED ON 12/11/2024
AVAILABLE BEFORE 2/10/2025
Responsibilities:
  • Independently leads EDC development, including CRF development, EDC specification process, edit check development and User Acceptance Testing including test scripts and execution logs, issue logs, and UAT summary reports.
  • Reviews and assists in the development of study documents drafted by CROs such as data transfer agreements, eCRF Completion Guidelines, and Data Management Plans.
  • Ensures the quality of clinical data within the EDC and other databases through data review and data reconciliation processes and communicates any outstanding issues.
  • Develops, in collaboration with the CRO, a clean patient tracker.
  • Coordinates transfers of SAS datasets or electronic data transfers from CROs.
  • Leads database lock process.
  • Monitors and tracks the quality of all data management deliverables ensuring audit practices have been enacted to validate the quality and assurance of database content and supporting documents.
  • Responsible for compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practice.
  • Effectively oversees contracted vendors, or vendor groups within CRO, to ensure data are complete, accurate and delivered within agreed on timelines.
  • Independently serve as the lead point of contact for all data management study-related communications.
  • Actively participates in team meetings and presents Data Management concerns risks and issues.
Requirements:
  • To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.
  • Bachelor's degree or equivalent in life science, computer science, or related discipline with 8 years' experience.
  • Minimum 5 years of experience working within a pharmaceutical or CRO environment, with experience in managing Phase I, II or III studies, from start-up through closure.
  • Demonstrated proficiency in various EDC Systems within the last 3 years.
  • Demonstrated proficiency in the data management processes.
  • Experience in managing external EDC vendors for Data Management.
  • Understanding of Clinical Data Interchange Standards Consortium (CDISC), CDASH, and SAS terminology.
  • Understanding of the coding process and terms in MedDRA, WHODRUG and CTCAE.
  • Thorough knowledge of applicable regulatory rules and guidelines.
  • Excellent organizational skills and attention to detail.
  • Effective communication and interpersonal skills.
  • Able to set priorities and juggle multiple projects and demands.
  • Able to think critically and independently and be a proactive problem-solver.
  • Able to lead and work independently while exercising initiative, flexibility, and sound judgment.
  • Comfortable working with different levels of the company including senior level management.
  • Demonstrated proficiency in Microsoft Word, Project, PowerPoint, Office, and Excel.

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