Senior Clinical Data Manager
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Job Description
Senior Clinical Data Manager overseeing project data management for clinical trials in Mexico. Collaborating with teams to ensure quality and timely data operations.
Responsibilities:
- Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) /program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
- Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
- Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality.
- Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
- Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
- Review and query clinical trial data according to the Data Management Plan
- Run patient and study level status and metric reporting
- Perform other duties as assigned
Requirements:
- Bachelors and/or a combination of related experience
- 8+ years’ experience OR Combination of qualifications and equivalent relevant experience may be accepted as an alternative.
- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
- Ability to communicate both verbally and in writing at the English proficiently (Professional level)
- Experience in utilizing various clinical database management systems
- Broad knowledge of drug, device and/or biologic development and effective data management practices
Benefits:
- Health insurance
- Retirement plans
- Flexible work arrangements
- Professional development
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