CLINICAL DATA MANAGER

Philogen S.p.A.; Siena; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading biotechnology company in Siena, Italy, is seeking a Clinical Data Manager to perform data management activities and support clinical trial processes. Ideal candidates have a Master's degree in healthcare and at least 2 years of relevant experience. This full-time position offers a contract and salary based on seniority and experience, ensuring compliance with clinical research standards.

Competenze

• 2 years of experience with clinical trial research and data management.
• Ability to work in cross-functional study teams.
• Good skills in data analysis.

Mansioni

• Design paper and/or electronic Case Report Forms in collaboration with the clinical team.
• Collaborate in the implementation and validation of clinical databases.
• Ensure data management in accordance with applicable standards.

Conoscenze

Meticulous attention to detail

Strong organizational skills

Ability to prioritize tasks

Good knowledge of MS Excel

Ability to communicate effectively

Knowledge of clinical research procedures

Formazione

Master's degree in healthcare or related field

Strumenti

MS Office

SAS

Descrizione del lavoro

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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