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Title:Clinical Data Manager
Salary:Open
Experience:4+
Location:MA - Cambridge

Description:
Performs tasks related to all aspects of the clinical trial data management process from study start up to database lock for both paper-based and EDC trials, for trials managed in-house, and those contracted to CROs.

Responsibilities:
  • Represents Data Management on Clinical Trial Working Groups
  • Designs CRF and clinical database structures for data acquisition and data entry
  • Identifies and resolves data flow process issues in collaboration with the project team
  • Defines data handling conventions, edit checks, quality acceptance and auditing criteria for electronic data as well as procedures for handling exceptions for violations to the standard metadata and identifies and requests additions to standard metadata
  • Creates standard and ad hoc reports to efficiently identify outstanding queries, query types per site, etc.
  • Resolves discrepancies and unresolved issues that arise during data entry
  • Assesses and reports on data outlier values
  • Identifies and reconciles SAEs
  • Identifies areas of manual data review where electronic checks are not effective
  • Uses available tools, systems and processes in support of the coding of medical terms
  • Communicates with vendors to define required file format and content specifications for electronic  files and establishes schedule and process for data transfers
  • Participates in the identification, review and evaluation of new data management technologies
  • Performs accurate database updates and follows up on query responses and errors identified in data cleaning
  • Drafts new Data Management Plans based on templates and Plans for similar protocol types
  • Documents database changes in the automated system audit trails and paper and electronic documentation
  • Liaises with third-party vendors such as CROs, EDC vendors and central laboratories in a project-manager capacity
  • Monitors timelines to ensure data management-related deadlines are met
  • Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Process Guides related to data management activities

Requirements:
  • BS degree with 4+ years or MS degree with 2+ years of experience in clinical data management, preferably in the pharmaceutical/-biotechnology industry; knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management.
  • Strong knowledge of SOPs, GCP standards and CDM systems
  • Detail oriented
  • Fundamental understanding of multiple computer applications

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