Clinical Data Quality Assessment Specialist

IDDI is hiring a Clinical Data Quality Assessment Specialist

With 28 years of experience, IDDI is seen as  a valuable partner in the design, conduct and analysis of clinical trials through optimal design, innovative statistical methodology and state-of-the-art web systems. With offices in Belgium and in Raleigh (NC, USA), IDDI has achieved very good results over the last few years. To sustain and develop this growth, for our Belgian offices, we are a Clinical Data Quality Assessment Specialist.

Job Description

As Clinical Data Quality Assessment Specialist you will :

  • Provide support to the Clinical Data Management (CDM) team in managing specific data entry and data review tasks under the supervision of the Lead CDM
    responsible for the project.
  • Provide support to the CDM programming team in executing Quality Control (QC) activities under the supervision of the CDM Programming Specialist and Lead Clinical Data Manager responsible for the projects.
  • Provide information and advice for questions on the data entry, data review and quality control activities.

Your responsibilities will be to:

  • Create annotated CRF
  • Perform Data Review activities:
    • Generate queries and review for consistency
    • Perform data modifications according to query answers
  • Perform the reconciliation of SAE and external vendor datasets (including resolution and follow-up of the inconsistencies)
  • Perform Quality Control (QC) activities:
    • Data entry of dummy data
    • Test reports, listings and patient profiles to ensure that they work correctly based on the dummy data entered
    • Report on findings and follow-up until resolution

QC activities are done on: annotated CRFs, SAS reports and SAS listings, patient profiles, checks, dummy unblinded datasets, IDDI standard and SDTM
tabulations, patient PDFs and data

  • Perform Data Entry activities:
    • Registration, verification, tracking of CRFs and other forms in CDMS prior to data entry and management in accordance with priorities
    • Data entry of CRFs and other forms; this also includes Laboratory Normal Ranges
    • Correction of inconsistencies between two entries
  • Provide support for the Coding activities: upload terms in ID-Code, communication with IDDI coders and medical reviewers, provide coding status and check out pending terms
  • Perform EDC data extracts (snapshots) either on pre-defined frequencies or upon request
  • File CRF pages. Send the patient PDF files either to the sponsor or investigator sites
  • Perform tasks in accordance with IDDI Standard Operating Procedures.

Your Profile

  • University degree in health related field or computer science or equivalent experience.
  • Knowledge of clinical trials
  • Experience in Data Entry and Data Review
  • Experience in using word processing software and spreadsheets (MS Word, Excel)
  • Good communication and interpersonal skills
  • Accuracy and attention to details
  • Ability to work in team environment
  • Working knowledge in English

Our Offer:

A unique opportunity to work in an innovative, dynamic and future-oriented company with a strong international environment. Join IDDI and contribute to the progress of clinical research! An inspiring and exciting career with international and challenging projects is waiting for you! We are looking for motivated, passionate and enthusiastic team players to help our clients accelerate delivery of their drugs. You will work with a dynamic, knowledgeable and international team with extensive clinical trial experience.

Interested in this challenging position ?

Please send your CV and cover letter in English as soon as possible.

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