Senior Clinical Data Manager

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

📋 Description

• Serve as the primary Data Management (DM) contact (Lead DM role) for designated clinical project(s)/program(s), ensuring backup, continuity, responsiveness, and timely execution of tasks.

• Supervise the project data entry process, which includes creating data entry guidelines, providing training, ensuring data entry quality, and allocating resources.

• Offer input, evaluate, and manage timelines. Ensure adherence to clinical data management deadlines while maintaining quality standards.

• Create Case Report Form (CRF) specifications based on the clinical study protocol and coordinate reviews/feedback from all relevant stakeholders.

• Conduct User Acceptance Testing (UAT) for database builds and maintain documentation that confirms quality control of the database build. Ensure overall quality of the clinical database.

• Review and query clinical trial data in accordance with the Data Management Plan.

• Generate patient and study-level status and metric reports.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• Bachelor's degree and/or a combination of relevant experience.

• A minimum of 8 years of experience, or a combination of qualifications and equivalent relevant experience may be considered as an alternative.

• Proficient in Microsoft Office Suite: Word, Excel, PowerPoint, Outlook.

• Capable of communicating effectively in both verbal and written English (Professional level).

• Experience with various clinical database management systems.

• Comprehensive understanding of drug, device, and/or biologic development along with effective data management practices.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Flexible work arrangements.

• Opportunities for professional development.