Pfizer

Manager, Clinical Data Scientist, Clinical Data & Information Sciences

Pfizer

full-time

Posted on:

Location Type: Office

Location: Thessaloniki • 🇬🇷 Greece

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Job Level

Mid-LevelSenior

Tech Stack

Google Cloud PlatformMS SQL ServerOracleSQL

About the role

  • Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials assuming responsibility for all CDS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence.
  • Serve as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reporting.
  • Partners with Research/Business Units, external DM service providers and internal CDS staff to deliver high quality data management for all studies as assigned.
  • Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team(s).
  • Ensure work carried out by or on behalf of CDS is in accordance with applicable SOPs and working practices.
  • Participates and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems.
  • Ensure the required study specific CDS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously.
  • Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release.

Requirements

  • Bachelor’s degree required
  • Degree in scientific field preferred
  • Master’s degree preferred
  • Minimum 5 years Data Management experience required
  • Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
  • Demonstrated successful experience in all relevant clinical data management activities in a Biopharmaceutical or CRO setting
  • Working knowledge of all phases of clinical trials and ability to assess and determine study requirement from protocol review
  • Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
  • Proficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC / Inform preferred)
  • Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g. Spotfire, jReview)
  • Familiarity with MedDRA/WHO-Drug
  • Strong Project and Risk Management
  • CRO and vendor oversight experience preferred
  • Strong verbal and written communication skills
  • Consistent, detail oriented, communicative, dedicated to do a job well done.
Benefits
  • Health insurance
  • Paid time off
  • Flexible working arrangements
  • Professional development opportunities
  • Remote work options

Applicant Tracking System Keywords

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

Hard skills
Data ManagementClinical Data ManagementDatabase DesignData CleaningData Integrity MonitoringData VisualizationRisk ManagementClinical Trial PhasesRegulatory RequirementsElectronic Data Capture
Soft skills
Project ManagementCommunicationDetail OrientedDedicationCollaborationProactivityOrganizational SkillsInterpersonal SkillsLeadershipQuality Assurance