Samir Allaoua

Structure patient record data for ongoing cohorts via the application, maintaining a regular pace.

Conduct preliminary studies: from brief with the sponsor to presentation in a dedicated meeting.

Supervise and define operational processes for Data Lab projects: determine who the owner is, what is needed, what are the inputs and outputs, timelines, etc.

Provide regular feedback to the Data Lab R&D team and actively participate in the design and improvement of products and algorithms.

Liaise with sponsors on launched projects, particularly on operational and medical issues (protocol cohort structure, required variables, possible values, etc.).

For a given project, determine the best ways to identify patients based on inclusion/exclusion criteria and qualify them.

Participate in the creation of monitoring dashboards for the first launched projects.

A. ARC Monitor Role:

Regulatory submissions

Coordination of a CRA team

Site selection and feasibility study

Lead and contribute to the initiation visit

Conduct on-site or remote monitoring visits

Risk-Based Monitoring

Reporting

Create and regularly share newsletters.

Study closure.

Manage overruns and budget according to pre-established grids.

B. Data Manager Role:

Development of the Data Management Plan (DMP)

Definition of variables from a protocol

Design of eCRFs (on Redcap, EnnovClinical, Cleanweb, Oracle, and Excel for databases)

Writing the data validation plan and developing validation checks

Integration of laboratory, ECG, imaging data, etc.

Detect data entry errors, issue queries, and correct them

Medical coding of medical history, adverse events, procedures, and treatments (MedDRA)

Management of interim analyses (Cut-off, point date)

Data import/export via SAS/SQL or in .csv format

Transmission of the raw database in the desired format (.sas, .xls, .txt, ...)

Database lock

Blind review

Regular reports

Archiving

Practical internship preceding a career change to Clinical Research Coordinator:

Enhancing clinical research.

Implementation, monitoring, and closure of clinical studies

Types of research and budgeting.