Pfizer

Data Manager

Pfizer

full-time

Posted on:

Location Type: Hybrid

Location: Thessaloniki • Greece

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About the role

  • Participate in CDIS activities including data review and query management.
  • Assist with quality database design including documentation, testing, validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
  • Ensure work carried out in accordance with applicable SOPs and working practices.
  • Ensure the required study-specific CDIS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities.
  • Ensure operational excellence in collaboration with Data Manager and Clinical Data Scientist for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities.

Requirements

  • Bachelor’s degree minimum requirement.
  • Minimum 1-3 years Data Management experience required.
  • Strong knowledge / understanding of clinical development and pharmaceuticals as a regulated industry.
  • Strong knowledge / understanding of healthcare regulatory authorities (e.g. FDA, Health Canada).
  • Ability to learn clinical data management processes and principles in area of responsibility.
  • Demonstrates required verbal and written communication skills including ability to communicate remotely.
  • Capable to learn technical data systems.
  • Capable to learn how to use data visualization tools (e.g. Spotfire, J-Review).
  • Awareness of MedDRA/WHO-Drug preferred.
  • Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
Benefits
  • Health Sciences experience or Technology degree preferred.
  • Strong knowledge / understanding of clinical development and pharmaceuticals as a regulated industry.
  • Strong knowledge / understanding of healthcare regulatory authorities (e.g. FDA, Health Canada).
  • Ability to learn clinical data management processes and principles in area of responsibility.
  • Demonstrates required verbal and written communication skills including ability to communicate remotely.
  • Capable to learn technical data systems.
  • Capable to learn how to use data visualization tools (e.g. Spotfire, J-Review).
  • Awareness of MedDRA/WHO-Drug preferred.
  • Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
data managementclinical data managementdata reviewquery managementdatabase designdata cleaningdata acquisitiondata visualizatione-data processingDM metrics reporting
Soft Skills
verbal communicationwritten communicationremote communicationcollaborationlearning ability