Study Coordinator/ Clinical Data Manager

About the job

Fondazione Icona ( a non-profit organization operating in the field of HIV clinical research, is looking for a Study Coordinator/Data Manager for a large multicentre observational study on people with HIV in Italy (ICONA Cohort Study).

Company: Fondazione Icona

Contract: Permanent contract, ‘CCNL Commercio’

Schedule : Full-time job

Experience : Mid-level

Working Location : Milan (Office of Fondazione Icona in Milan)

Activities

Provide clinical data management support, including the following activities:

·         Review and update clinical study documents (e.g. protocols, consents etc.);

·         Prepare the documentation required for submission to the Ethics Committee of any amendment or start-up of new studies and contact with the Clinical Trial Units and the local PIs and collaborators;

·         Coordination with the administrative staff of Fondazione Icona for the study contracts in the new centers;

·         Support to the staff of the participating centres for data entry and the study procedures;

·         Evaluation of the quality and completeness of the data collected through remote and on-site contacts with the centers;

·         Support for any procedure of the ICONA study protocol and sub-studies, including shipment of biological samples and documents.

·         In cooperation with the biostatistical unit and other data managers of Fondazione Icona, data extraction and preparation of study data for subsequent analyses;

·         Prepare periodic monitoring of study activities and contribute to the presentation of the results;

Requirements:

• Bachelor’s or Master’s Degree in scientific subjects (Biology, Biotechnology, Pharmacy, Nursing or equivalent);
• Commitment to advancing scientific knowledge;
• 1-3 years’ experience in the field of clinical research
• Overall good IT skills and analytical skills
• Up to date on regulations regarding clinical data collection and on clinical data standards such as: GCP (Good Clinical Practice), GCDMP (Good Clinical Data Management Practices), and data privacy like GDPR (General Data Protection Regulation)
• Good knowledge of English and native/fluent Italian
• Will also be considered an advantage:

• previous experience in handling large, complex datasets using any language or software for data handling (mySQL, R, Python, ETL tools);
• previous experience in the project management and coordination of large multicentre observational studies