CLINICAL DATA MANAGER

Location

Siena (SI) | Italy

Job description

Job Title: CLINICAL DATA MANAGER

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 multi-tasking skills
• Excellent attention to detail and problem-solving skills
• Windows applications: Word, Excel, Powerpoint, etc.
• A previous experience in a similar role is preferred

We offer:

A contract and salary proportional to the experience of the successful candidate.

Job location:

Siena – Italy

Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address [email protected], specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).

Job tags

Salary