Clinical Data Reviewer

IDDI (International Drug Development Institute), founded in 1991, is a highly recognized biostatistical and eClinical data service provider in the field of clinical research, providing agile clinical trials services for pharmaceutical, biotechnology, and medical device/diagnostic companies. Together, we want to achieve one objective: support our clients to accelerate the delivery of their drugs and improve people’s health.

To support our growth and commitment to quality and innovation, we are actively looking for a dynamic Clinical Data Reviewer (CDR) to reinforce our team in the US (Raleigh, NC).

CLINICAL DATA REVIEWER

Your role:

As a CDR , you will provide support to the Clinical Data Management team performing end-to-end data management for complex medical research projects in a diverse range of therapeutic areas. You will assist in managing specific data entry tasks, data review tasks, and quality control activities.

You will be part of a dynamic and experienced team and report directly to the Team Leader, CDR. Based on your experience, and to help you thrive in your role and develop your career, you will receive the necessary trainings, mentoring, and coaching from your peers.

Your responsibilities:  

  • Create annotated CRF
  • Perform Data Review activities:
    • Generate queries and review for consistency
    • Perform the manual cleaning of clinical data based on SAS edit checks and/or listings and post the relevant queries in the EDC system
    • Review the answered automatic queries in the EDC system, close them or ask for more clarification
    • Perform data modifications according to query answers (if applicable)
  • 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
  • Perform Data Entry activities:
    • 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
  • Perform EDC data extracts (snapshots) either on pre-defined frequencies or upon request.

Your profile: 

  • Master’s 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:

You will join an international and multi-cultural company that includes over 25 different nationalities (English is the working language) and where employees are the strongest asset.

At IDDI, we offer job stability and growth opportunities through on‑the‑job training and mentoring programs. Working at IDDI will bring you an expertise that is widely recognized in our industry.

Our customers value our flexibility, responsiveness, and proactive approach.

A unique opportunity to work in a friendly, team-oriented, and stimulating environment. We regularly enjoy company-wide events, such as BBQs, family-day outings, sports, and charity fundraisers – giving the chance to share time together.

We offer a competitive salary and benefits package including health, dental and vision insurance plans, short- and long-term disability insurance, life insurance as well as flexibility for a better work-life balance (flexible working hours, home-working opportunities, paid time off).

Interested in this challenging position?

Please send your CV and cover letter highlighting your motivation and relevant professional experience for the position by e‑mail at careersUSA@iddi.com (to the attention of Andrea Golder).