Senior Clinical Data Manager Job at cGxPServe, Charlotte, NC

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  • cGxPServe
  • Charlotte, NC

Job Description

Responsibilities:
  • Represent Data Management in study team meetings, providing metrics and guidance on data-related issues.
  • Oversee Data Management activities from study start-up to close-out.
  • Develop and manage study timelines and ensure the quality and timeliness of data from service providers (e.g., Central Reading Centers, Labs, Medical Coders).
  • Author key documents, including Data Management Plans, Data Review Guidelines, eCRF Completion Guidelines, and study timelines.
  • Prepare training materials for Investigator Meetings, internal teams, and site staff.
  • Maintain all Data Management project documentation in an audit-ready manner.
  • Support Lead Clinical Programmers in developing and managing Data Transfer Agreements.
  • Lead regular data review across studies, identifying quality issues, trends, and outliers, and generate queries as needed.
  • Reconcile data from external sources.
  • Assist in creating CRF and Edit Check Specifications.
  • User Acceptance Testing (UAT) of clinical databases, including EDC systems.
  • Manage EDC User Access for all assigned studies.
  • Provide day-to-day support to Clinical Study Teams to ensure data is reviewed and discrepancies are resolved.
  • Collaborate with internal stakeholders to meet study timelines and deliverables.
  • Work with Clinical Programming to produce reports for efficient data review and cleaning.
  • Facilitate cross-functional Data Management meetings with Study Managers, Project Managers, Programming, and Regulatory teams.
  • Review study protocols and provide feedback on data collection methods.
  • Participate in updating Data Management standard operating procedures, work instructions, and templates.
  • Contribute to the development and improvement of departmental processes.
Requirements:
  • Bachelor's degree or higher in biological science, nursing, or a related health field preferred.
  • Minimum of 7 years of experience in clinical data management, preferably within the pharmaceutical or medical device industry.
  • Strong understanding of clinical trial processes, FDA/ICH guidelines, and Good Clinical Data Management Practices (GCDMP).
  • Hands-on experience with Electronic Data Capture (EDC) systems such as MedNet, Rave, and Veeva Vault EDC.
  • Proficiency in data review and use of reporting/analytics tools.
  • Excellent project management and documentation skills, with experience writing Data Management Plans, Data Review Guidelines, and study timelines.
  • Strong verbal and written communication skills.
  • Ability to manage multiple clinical studies and tasks simultaneously.
  • Knowledge of CDISC Standards (CDASH, SDTM).
  • Problem-solving skills and flexibility in responding to business needs.
  • Ability to identify and mitigate risks to data quality proactively.
  • Experience in ophthalmology therapeutic areas.
  • Familiarity with Case Report Form and Edit Check Specification development.

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