Senior Clinical Data Analyst

We are currently looking for a Senior Clinical Data Analyst (SCDA) to join our team in Mexico. The SCDA will independently lead and coordinate clinical data validation activities. Also, will provide technical expertise in Data Management operations and documentation. Additionally, SCDA ensures compliance with quality standards, SOPs, ICH-GCP, and regulatory requirements. Acts as subject matter experts on DM systems/processes, offers technical support to internal and external sponsors and may serve as backup or fulfill Data Management Lead role when needed.

Key Accountabilities:

• Data Validation: Lead data cleaning, review, and reconciliation activities.
• Documentation: Prepare and maintain DM documents as per SOPs and guidelines.
• Study Start-Up: Conduct UAT on clinical database setups and review protocols. Quality Management: Ensure compliance with SOPs and ICH/GCP guidelines.
• Training: Maintain compliance, provide on-the-job training, and act as mentor.
• Process Improvement: Develop and implement efficient project-specific tools. Project Finance: Monitor and analyze DM operational metrics.

Skills:

• Leadership and collaboration in global, cross-functional teams.
• Independent interaction with sponsors.
• Problem-solving and decision-making in ambiguous situations.
• Strong attention to detail and commitment to quality.
• Excellent time management and communication skills.
• Adaptability and innovative thinking.

Knowledge and Experience:

• Advanced technical aptitude in Microsoft Office and DM systems.
• Thorough understanding of DM processes and ICH-GCP guidelines.
• Proficiency in at least one Clinical Data Management System (e.g. InForm, Rave, Veeva, DataLabs, ClinBase.)
• Experience in clinical research industry.
• Advanced knowledge of medical terminology and coding dictionaries.
• Basic knowledge of SAS and CDISC standards.
• Understanding of DM project financials.
• Good English skills.