Data Manager – Clinical Trials

This is a fully remote position, open to applicants in Italy.

📋 Description

• Oversee the setup, testing, maintenance, and entry of database information.

• Liaise with clients, project teams, and vendors regarding data management issues.

• Evaluate study documents and create project-specific guidelines and instructions.

• Develop electronic Case Report Forms (eCRF), Data Management Plans, and Data Validation Plans, and conduct testing of Electronic Data Capture (EDC) databases.

• Ensure accurate data entry, follow-up, and validation, including manual review of Case Report Forms (CRF) and reconciliation of Serious Adverse Events (SAE).

• Code medical data appropriately.

• Monitor and report metrics that lead to database lock.

• Coordinate the processing, distribution, and archiving of CRFs and related queries.

• Maintain working files for Clinical Data Management.

• Conduct quality control checks on databases and prepare for and participate in audits.

• Provide training to site staff and project teams on CRF completion and data management topics.

⛳️ Requirements

• A degree from a college or university (a degree in Life Science or Pharmacy is an advantage).

• Proven experience in managing clinical or medical data within a Contract Research Organization (CRO) is essential.

• Proficient in English at a professional level.

• Familiarity with Clinical Data Management systems (such as Medidata Rave or Oracle InForm).

• Strong proficiency in MS Office applications.

• Excellent organizational and time management abilities.

• Capability to work independently and handle multiple tasks simultaneously.

• Please submit your CV in English.

🏝️ Benefits

• Additional compensation options include bonuses, incentive plans, and other potential benefits.

• Employees have the option to work remotely.