Senior Clinical Data Manager

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

📋 Description

• Ensure the data collected from various clinical trials is managed, reported, and captured in a clear, accurate, and secure manner.

• Oversee data management tasks across studies, from protocol evaluation to database lock.

• Monitor the status of studies, including participant enrollment and the monitoring/approval of CRFs.

• Present project deliverables to clients, collect their feedback, and suggest solutions.

• Provide the project team with regular reports on data status.

• Supervise the work of Clinical Data Coordinators and external vendors.

• Maintain the clinical database, which includes data review and cleaning during the study and preparing for database closure/lock.

• Reconcile external data with EDC data, including sponsor safety databases related to adverse and serious adverse events.

• Create data management plans.

• Design electronic Case Report Forms (eCRFs) and independently construct clinical databases using the selected EDC system or in collaboration with an EDC programmer.

• Coordinate the validation of clinical databases and user acceptance testing.

• Assist in the development and testing of external clinical data systems like ePRO and IWRS.

• Create eCRF completion guidelines and training materials.

• Train site users and monitors on the clinical database.

• Activate or deactivate clinical database users and maintain records of requests.

• Respond to user inquiries regarding EDC system assistance.

• Generate data listings and reports for database closure/lock.

• Ensure that data management documentation is complete and up-to-date in the trial master file.

• Archive the clinical database and associated documents.

⛳️ Requirements

• Bachelor’s or Master’s degree in a relevant field.

• 7 years of experience in clinical data management within the pharmaceutical industry or a CRO setting.

• 3 years of experience as a lead data manager.

• Extensive experience with EDC systems; familiarity with Medrio and Medidata Rave is preferred.

• Highly organized and detail-oriented.

• Strong project planning and time management abilities.

• Excellent verbal and written communication skills in English.

• Understanding of the drug development process and relevant regulations, including Good Clinical Practices (GCP) and ICH Guidelines.

• Good knowledge of CDISC SDTM/CDASH standards.

• Familiarity with MedDRA and WHODrug dictionaries is an advantage.

• Must have legal authorization to work in Spain.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Opportunities for ongoing learning and development.

• Attractive possibilities for advancement.