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Freelance Clinical Data Manager

Are you an experienced Freelance Clinical Data Manager having room for an additional assignment ? Do you like data cleaning and database lock related activities ? Don't hesitate and apply to this exciting project opportunity now !

Job Description

As a Freelance Clinical Data Manager you will be providing Data Management support to the clinical study team. For this specific request the focus as Freelance Clinical Data Manager will be on data cleaning support and database lock related activities.

Responsibilities

  • Assist in defining and/or create data listings, summary tables, data reports, status reports (in excel and PDF forms) to support data review (including medical data review, data review by sponsor, coding data review, systematic data review by data manager, reconciliation data review etc.,)
  • Process queries generated using automatic checks and performs comprehensive manual data review on clinical data.
  • Identify data related issues during data review and work towards resolution.
  • Interface between site and data management to ensure prompt query resolution.
  • Participate in the review of Clinical research documents (e.g. Protocols, Case Report Forms, Reports and Statistical analysis).
  • Support in development of Case Report Form (CRF), electronic and/or paper.
  • Support in development database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, and query logic and data validations, Data management documents.
  • Support in reconciliation of electronic data transfers from vendor to Sponsor.
  • Develop test scripts and execution logs for User Acceptance Testing (UAT).
  • Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
  • Support to Data manager in EDC access management.
  • Provide data management support during Audits.
  • Participate in conference calls and/or meetings with vendors.

Requirements

  • Bachelor's degree in a science/IT related field
  • At least 1-2 years of relevant experience within Data management in Clinical Trial sector, either within industry or within a non-profit organization or CRO.
  • Experience preferred in clinical data review and the use of review and listing tools
  • Basic working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Good knowledge of Office tools mainly Microsoft Excel.
  • Working knowledge of Clinical database applications for EDC.
  • Applicable knowledge working with clinical databases such as Oracle Clinical, Oracle etc., SAS, Coding of medical terms etc.,
  • Enthusiastic person, pro-active, reliable, and flexible. Team player with the ability to work independently and autonomously.
  • Excellent verbal and written communication skills in English. Any other language is a plus. Good organizational, interpersonal, and team skills.
  • Good Project coordination skills.
  • Existing right to work in Europe required

Benefits

  • A balanced salary package based on your capabilities and experience.

Vacancy number: 18732