Senior Clinical Data Manager

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

📋 Description

• Accountable for managing all facets of the clinical trial data management process from the initiation of the study through to the post-database lock phase for designated projects.

• Supervise and/or execute database development and testing activities.

• Ensure backup, continuity, responsiveness, and timely execution of tasks.

• Manage the project data entry process, including the creation of data entry guidelines, training, quality assurance of data entry, and resource allocation.

• Guarantee that clinical data management deadlines are achieved with a focus on quality.

• Create CRF specifications based on the clinical study protocol and coordinate feedback from all relevant stakeholders.

• Conduct user acceptance testing (UAT) for database builds and maintain documentation for quality-controlled database builds. Oversee the overall quality of the clinical database.

• Responsible for developing, updating, appropriately versioning, and maintaining data management documentation.

• Educate clinical research personnel on study-specific CRF, EDC, and other project-related materials as necessary.

• Execute line listing data reviews according to the guidance provided by the sponsor and/or Lead DM.

• Collaborate with third-party vendors, including external data and EDC vendors, in a project management role to support timelines and data-related deliverables.

• May assist with SAS programming and the quality control of SAS programs used within the Data Management department.

⛳️ Requirements

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

• Proficiency in both verbal and written communication in English at a professional level.

• 8+ years of experience OR a combination of qualifications and equivalent relevant experience may be considered as a substitute.

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

• Exceptional organizational and communication abilities.

• Professional command of the English language, both written and spoken.

• Experience with various clinical database management systems.

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

• Strong representational skills with the ability to communicate effectively both verbally and in writing.

• Strong leadership and interpersonal capabilities.

• Willingness to undertake occasional travel.

🏝️ Benefits

• Employee health insurance.

• Paid time off.

• Professional development opportunities.