Clinical Data Manager - Siena, Italia - Philogen

Philogen

Azienda verificata

Siena, Italia

1 settimana fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Location:
Siena
Italy

***
Department: Clinical
***Philogen S.p.
A. would like to hire a
CLINICAL DATA MANAGER to support our Clinical Department.

Responsibilities:

Perform data cleaning activities on assigned studies
Design paper and/or electronic Case Report Forms (CRFs) in collaboration with the clinical team
Collaborate in the implementation and validation of clinical databases
Prepare, maintain and archive data management documentation (e.g. Data Management Plan)
Review all the clinical data listings and tables
Ensure data management in accordance with applicable standards (e.g. CDISC), regulatory guidelines and company SOPs
Participate in study team meetings
Support the Pharmacovigilance department in SAEs reconciliation
Manage discrepancies
Review clinical study protocols and Clinical Study Reports
Perform coding activities using medical dictionaries
Perform database lock process

Experience Requirements:

-
Minimum Bachelor's degree (health, clinical, biological or pharmaceutical science - or a related field preferred) with 2-3 years equivalent level of experience in pharmaceutical/biotech, or CRO setting or Master's degree without any equivalent level of experience in pharmaceutical/biotech, or CRO setting

Extensive experience working with data management on data checking
Knowledge of SAS system and data standards (CDISC) is considered a plus
Knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
Strong interpersonal, organizational, and multitasking skills
Excellent attention to detail and problemsolving skills
A previous experience in a similar role is preferred

We offer:

Job location: