cGxPServe

Senior Clinical Data Manager

Matthews, NC, US

12 days ago
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Summary

Responsibilities

  • Support the Lead Data Manager across one or more clinical studies.
  • Reviews protocols for appropriate data capture including electronic (eCRF) design.
  • Support CRF design, review, and validation of clinical database.
  • Provide expertise and support oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.
  • Reviews or generates study documents (Data Management Plan, CRF Completion Guidelines, DB build specifications, Edit Check Specifications, Data Transfer Specifications, SAE and/or External Data Reconciliation Plans, Coding Guidelines, Vendor Management Plans, etc.).
  • Review CRF metrics reports against project data deliverables.
  • Conducts oversight of data management vendors via ongoing review of quality and performance metrics.
  • Leads the Data Review plan check, specification and validation updates.
  • Facilitates and participates in scheduled and ad hoc data listing review.
  • Generates, resolves, and tracks data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications.
  • Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
  • Reviews and provides feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.
  • Maintains study DM related documents/files for inspection readiness.
  • Conducts the SAE and external vendor data reconciliation.
  • Review and may distribute/coordinate data management metrics, listings, and reports.
  • Responsible for maintaining internal data management timelines and metrics. Maintains study DM related documents/files for inspection readiness.
  • Proactively identifies potential data management issues/risks and communicates it within the study team for further action.
  • Participate in process improvement activities resulting in increases in productivity, quality, and/or cost effectiveness.

Requirements:

  • Minimum BA/BS in scientific or health-related field.
  • Minimum of 9-11 years of clinical data management experience in the pharmaceutical, and biotechnology industry or in a CRO.
  • At least 1 year experience working at a Sponsor.
  • Oncology trial experience required, hematology/oncology preferred.
  • Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to DM practice.
  • Proficient with Medidata RAVE.
  • Experience with working on Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.
  • Familiarity with various data visualization, analytics, and reporting tools is a plus.
  • Excellent communication skills (verbal and writing).
  • Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting.
  • Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.).
  • Strong organizational skills and ability to prioritize tasks.
  • Proven ability to work independently and in a team setting.

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