Digital Expert Milano

Digital Expert
Milano
Lombardia, Milano

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a **Digital Expert **who can join an exciting working environment in a dynamic atmosphere.

**JOB DESCRIPTION**:

The digital expert:

- Collaborates with GCD (Global Clinical Development) Digital Unit on digital project management and execution;

- Carries out technical activities linked to GCD electronic systems and digital projects;

- Supports GCD end users in the electronic system usage;

- Provides input to GCD digital portfolio maintenance and enhancement;

- Supports GCD electronic systems validation (as per applicable regulations) in collaboration with GCD Digital Unit;

- Develops and maintains the GCD WebSite.

**RESPONSIBILITIES**:

- EDC system (Medidata RAVE) administration

- iMedidata Cloud administration

- EDC modules (e. g. , Targeted Source Data Verification) configuration at study level

- Business Objects reports implementation

- Integration via API between Company EDC HOUSE and external systems (e. g. , CRO CTMS)

- Digital project management:

- Planning

- technical support

- oversight of deliveries

- documentation

- system validation.

- Support to GCD electronic system validation in collaboration with relevant R&D/GCD functions

**REQUIREMENTS AND SKILLS**:

- University Degree in IT/Scientific Disciplines

- At least 10 years of experience as IT expert in pharmaceutical companies or international CRO

- Good knowledge of regulations and guidelines on electronic systems management and validation (e. g.

GAMP, FDA 21 CFR Part 11)

- Good knowledge of drug development process and ICH GCP guideline

- IT project management

- Data standards and models (CDISC, OMOP)

- Data visualisation and reporting tools

- Electronic system administration and validation

- IT Cloud infrastructure knowledge

- Solid knowledge of clinical digital trends

- Deep knowledge of clinical study data collection tools (e. g. , eCRF, IRT, spirometry platform)

- iMedidata Cloud

- Medidata RAVE and modules (e. g. , RTSM, eCOA, TSDV)

- Medidata API

- SAS Cloud

- Business Objects

- Microsoft Azure

- Microsoft SharePoint

- Proficient written and spoken English

**TYPE OF CONTRACT**:

Long Term contract - Staff Leasing