For one of our clients, a multicutural and family-oriented company, we are actively looking for a Clinical Data Quality Assessment Specialist (M/F).
- Have a University degree in health related field or computer science or an equivalent experience;
- Have experience in Data Entry and Data Review;
- Are fluent in English, and able to work in an English-speaking environnement;
Then, this opportunity might be the next step in your career !
As Clinical Data Quality Assessment Specialist, you 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. You 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. You provide information and advice for questions on the data entry, data review and quality control activities.
- You create annotated CRF
- You perform Data Review activities:
- You generate queries and review for consistency;
- You perform data modifications according to query answers.
- You perform the reconciliation of SAE and external vendor datasets (including resolution and follow-up of the inconsistencies).
- You perform Quality Control (QC) activities (QC activities are done on: annotated CRFs, SAS reports and SAS listings, patient profiles, checks, dummy unblinded datasets, the company's standard and SDTM tabulations, patient PDFs and data):
- You ensure data entry of dummy data;
- You do the test reports, listings and patient profiles to ensure that they work correctly based on the dummy data entered;
- You write report on findings and follow-up until resolution.
- You perform Data Entry activities:
- You ensure the registration, verification, tracking of CRFs and other forms in CDMS prior to data entry and management in accordance with priorities;
- You perform data entry of CRFs and other forms; this also includes Laboratory Normal Ranges;
- You correct the inconsistencies between two entries.
- You provide support for the Coding activities: upload terms in ID-Code, communication with the coders and medical reviewers, provide coding status and check out pending terms.
- You perform EDC data extracts (snapshots) either on pre-defined frequencies or upon request.
- You file CRF pages. You send the patient PDF files either to the sponsor or investigator sites.
- You perform tasks in accordance with the company's Standard Operating Procedures.
- You hold a University degree in health related field or computer science or equivalent experience.
- You have a GCP training
- You have knowledge in clinical trials
- You have experience in Data Entry and Data Review
- You have experience in using word processing software and spreadsheets (MS Word, Excel)
- You have good communication and interpersonal skills
- You are accurate and you pay attention to details
- You are able to work in a team environment
- You are fluent in English, and able to work in an English-speaking environnement
+32 10 68 53 30