CLINICAL DATA MANAGER

Direct message the job poster from Philogen S.p.A.

Philogen S.p.A. is a biotechnology company whose mission is the development of biologic products for the imaging and therapy of life-threatening diseases, with a strategic focus on cancer diseases and rheumatologic disorders.

Overview

Philogen S.p.A. would like to hire a highly motivated and qualified Clinical Data Manager who will report to the Data Manager Coordinator.

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
• Review clinical study protocols and Clinical Study Reports
• Perform coding activities using medical dictionaries

Qualifications

• Master's degree in healthcare or a related field;
• 2 years of experience with clinical trial research and data management;
• Meticulous attention to detail;
• Strong organizational;
• Ability to prioritize tasks and handle multiple projects at once and stressful situations;
• Ability to work in cross-functional study team
• Knowledge of clinical research procedures and regulations;
• Good knowledge of MS Excel and Office packages in general;
• Good skills in data analysis;
• Ability to communicate effectively (both verbally and in writing);
• A clear understanding of the benefits of clinical trial research.

Preferred skills

• Knowledge of medical terminology with expertise in oncology preferred;
• Knowledge of coding dictionaries (e.g. MedDRA);
• SAS Knowledge

We offer

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

Details

• Job location: Siena, Tuscany, Italy
• Seniority level: Associate
• Employment type: Full-time
• Job function: Research
• Industries: Pharmaceutical Manufacturing

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