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Senior Clinical Data Manager
hace 4 semanas
We are looking for a Senior Clinical Data Manager to strengthen our clinical operations in Mexico
Job Requirements:
- Strong knowledge of ICH-GCP, local and international regulations, and clinical trial protocols
- Experience in vendor management and regulatory compliance
- Strong knowledge of SDTM and knowledge of SQL
- Minimum 3 years of experience in clinical trial industry as a Clinical Data Manager or similar position
- Proficiency in clinical data processing, medical coding (MedDRA), and database validation
- Expertise in eCRF design, data management plans (DMP), and data transfer specifications
- Strong leadership skills to supervise and allocate tasks to clinical data managers
- Ability to collaborate with cross-functional teams, including Clinical Operations, Pharmacovigilance, and Business Development
- Excellent organizational, problem-solving & multitasking skills
Job Responsibilities:
- Ensure compliance with ICH-GCP, regulatory requirements, and study protocols
- Manage vendor relationships and ensure data management licenses are obtained
- Supervise and allocate data management staff to studies, ensuring timelines are met
- Oversee clinical trial data cleaning, query workflows, and medical coding
- Design and validate clinical databases, eCRFs, and implement logic checks
- Develop and maintain Data Management Plans (DMP) and Data Transfer Specifications
- Participate in internal and external audits of the Data Management department
- Maintain billing trackers and optimize processes for efficiency
- Provide support and guidance to internal teams, including Clinical Monitoring and Pharmacovigilance
What We Offer:
- Flexible working hours and home-based working option
- Great work-life balance (You will not be overwhelmed with projects as we believe in quality over quantity)
- Career growth and development opportunities in a continuous learning culture
- Friendly environment in a privately owned international company
- Additional paid day off on your birthday
You can apply via the link or send a CV directly to:
*SanaClis is an equal opportunity and inclusive employer
Seniority level- Mid-Senior level
- Full-time
- Research, Analyst, and Information Technology
- Research Services
