Clinical Data Manager Modena

Clinical Data Manager
Modena
Emilia Romagna, Modena

IQVIA is a leading global provider of contract research services, strategic consulting services and innovative technology solutions, dedicated to using analytics and science to help healthcare stakeholders find better solutions for their patients.

**Why to join IQVIA

With IQVIA, you'll have access to one of the world's highest-regarded service organizations in the Life Science Sector, providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects for PharmaCos, Biotech & Medical Device Companies.

Our connections to the whole Health Care Ecosystem can lead you to innovative research pursuits you'll be proud to help advance.

In this role, you will be responsible for verifying that the data collected are aligned for the quality and quantity study's expectations.

While projects vary, your typical responsibilities might include:

- Draft the Data Validation Plan, ensuring that all controls set up for the data cleaning are properly reported

- Draft the Data Management Plan (DMP) and share it with the study team and with the Clients until its final approval

- Coordinate and execute the coding activities (by using the known dictionaries, e. g.

MeDRA, WHO etc), drug safety reconciliation and data review

- Set and create the data base and support the development of the study eCRF and then validate them, assessing the correct functionality of the eCRF developed, in compliance with the applicable quality validation standards

- Execute the quality control of the Checks & Self Evident Corrections (SECs) programmed for the data cleaning

- Analyze the emerged queries

- Ensure that all required corrections are properly implemented in the DB

- Data Entry management, ensuring that all the involved data entry clerks have been properly trained, providing all requested clarification related to the data entry activities

- Support SM in the draft of the Monitoring Plan

- Deliver the final Data Base to the Sponsor, using adequate tools and electronic support

- Support the team in research and development activities

**Desired Skills and Experience

- ** MSc** Degree, preferably in biomedical, biological, chemical or pharmaceutical or computer sciences

- Knowledge in pharmacology and drugs lifecycle

- Proven ability to use statistical software, preferably **SAS**:

- Knowledge in the creation and management of the **data base**:

- Knowledge of the main project management techniques (GANTT and project's monitoring)

- Knowledge of ICH-GCP

- Strong **analytic** and quantitative background

- Excellent Microsoft Office Skills: strong skills in working with **Excel** spreadsheets

- Proficiency both in **English** and Italian

Location: Modena

Candidature SENZA i requisiti richiesti non saranno prese in piena considerazione.

Si prega di inserire l'autorizzazione al trattamento dei dati personali ai sensi dell'art.

13 d. lgs.

30 giugno 2003 n°196 - "Codice in materia di protezione dei dati personali" e dell'art.

13 GDPR 679/16 - "Regolamento europeo sulla protezione dei dati personali".

La ricerca è di carattere urgente ed è rivolta ad entrambi i sessi (L. 903/77).