Clinical Data Coordinator

4 weeks ago

Beijing, Beijing, China Parexel Full time

About the Role:

The Clinical Data Coordinator will be responsible for the triage of incoming reports, ensuring their completeness, legibility, and validity. This involves initial data entry of case reports into safety databases and tracking systems. The successful candidate will also be responsible for follow-up requests, safety database administrative activities, case reconciliation, and line listing and tabulation generation for safety reports.

Key Responsibilities:

  • Triage of incoming reports for completeness, legibility, and validity
  • Initial data entry of case reports into safety databases/tracking systems
  • Follow-up requests (written, telephone)
  • Safety database/tracking system administrative activities
  • Case reconciliation
  • Line listing and tabulation generation for safety reports
  • Ad hoc queries
  • Quality Assurance activities (assisting in audits, developing templates and guidelines)
  • Organizing translation of study documents with external vendors
  • Supporting registration with relevant authorities for electronic reporting on behalf of the sponsor
  • Supporting the setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
  • Supporting the submission of safety reports to investigators via ISIS
  • Tracking and filing of submission cases as required
  • Collection and review of metrics for measuring reporting compliance and project-specific operational performance
  • Measuring investigative site performance in conducting required tasks
  • Unblinding of SUSARs, as required and as appropriate
  • Providing internal support to SSPMs as a project resource, supporting internal processes and systems setup and reporting activities
  • Supporting the development and maintenance of Central Files Maintenance Plans (CFMP)
  • Performing filing and archiving (filing documentation in departmental working files and submitting information to central files)
  • Preparing draft project plans, including all sub-plans per templates (Communication plan, Risk Management plan, MSP, WSOP listing, Quality plan, etc.)
  • Initiating, setting up, and maintaining Management Systems on a regular basis (GXDB, CTMS, PMED, other systems as required)
  • Preparing project-related data for analysis (TIME/task code analysis, operational metrics, and compliance reports)
  • Arranging project-related training and maintaining project-specific training overviews and records, including study-specific system training members (e.g., ARGUS, ISIS, PMED)
  • Conducting project close-out in management systems at the end of the project (GXDB, ARGUS, PMED, and other systems as required)
  • Supporting the collection and organization of global Safety Services requirements
  • Data entry and maintenance of country-specific requirements in PAREXEL's Safety Services repository
  • Receipt and triage of requests for updates to country requirements
  • Communicating country-specific regulatory updates to project teams as required
  • Maintaining an updated network list of Named Safety Contacts/LQPPV
  • Working directly with relevant stakeholders on standalone GPIO projects
  • Assisting Medical Directors/Safety Physicians as needed in project-related tasks
  • Arranging and attending project meetings as needed

Requirements:

  • Analytical and problem-solving skills
  • Able to perform basic searches via the internet or other comparable data repositories
  • Good interpersonal skills
  • Good verbal/written communication skills
  • Good organizational and prioritization skills
  • Ability to work collaboratively and effectively in a team environment
  • Client-focused approach to work
  • Knowledge of medical terminology
  • Experience with computer applications

Education:

  • Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
  • Associates/diploma degree in any of the above with appropriate work experience

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