Data Manager – Clinical Trials

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

📋 Description

• Oversee the establishment, testing, upkeep, and data entry of databases.

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

• Examine study documents, and create tailored project guidelines and instructions.

• Develop electronic Case Report Forms (eCRF), Data Management Plans, and Data Validation Plans, as well as test Electronic Data Capture (EDC) databases.

• Ensure accurate data entry, follow-up, and validation, which includes manual CRF reviews and Serious Adverse Event (SAE) reconciliation.

• Code medical information accurately.

• Monitor and report metrics that lead to the locking of databases.

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

• Maintain working files for Clinical Data Management.

• Conduct database Quality Control (QC) checks, and prepare for and participate in audits.

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

⛳️ Requirements

• A degree from a college or university (Life Science or Pharmacy degree is advantageous).

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

• Full proficiency in English is required.

• Familiarity with Clinical Data Management systems (e.g., Medidata Rave, Oracle InForm) is necessary.

• Competence in MS Office applications is expected.

• Strong organizational and time management capabilities are essential.

• Ability to work independently while managing multiple tasks is required.

🏝️ Benefits

• Bonuses.

• Incentive plans and additional benefits may be applicable.