Sr Clin Data Assoc
HybridMexico City, Mexico City, Mexico
Job Summary
Support study startup activities, including database design review, User Acceptance Testing (UAT), and Data Validation Manual (DVM) development. Perform ongoing review, cleaning, and reconciliation of clinical data to ensure accuracy, completeness, consistency, and compliance with study requirements. Generate, track, and resolve data queries while maintaining the integrity and quality of the clinical database. Independently manage data management deliverables across multiple studies while meeting project timelines and quality expectations. Serve as the subject matter expert for study-specific data management processes, providing technical guidance to project teams. Prepare and communicate project status updates to internal stakeholders and clients. Identify process improvement opportunities and contribute to global Clinical Data Management initiatives. Mentor and provide day-to-day guidance to junior team members, fostering technical growth and knowledge sharing. Collaborate effectively with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, and other cross-functional teams to support successful study execution. Ensure all activities are performed in compliance with Good Clinical Practice (GCP), ICH guidelines, regulatory requirements, and company SOPs.
Required Qualifications
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related scientific discipline, or an equivalent combination of education and relevant experience
- Minimum of 3–5 years of Clinical Data Management experience within the pharmaceutical, biotechnology, CRO, or medical device industry
- Demonstrated experience managing multiple clinical studies simultaneously
- Experience with Electronic Data Capture (EDC) systems and clinical database management
- Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and Clinical Data Management principles
- Solid understanding of clinical trial protocols, CRFs/eCRFs, edit checks, Data Validation Manuals (DVMs), and database lock activities
- Excellent analytical, critical thinking, and problem-solving skills
- Exceptional attention to detail and commitment to data quality
- Strong organizational skills with the ability to prioritize multiple studies and meet competing deadlines
- Excellent written and verbal communication skills
- Strong interpersonal skills with the ability to build collaborative relationships across global teams and clients
- Ability to maintain strict confidentiality of clinical and proprietary client information
- Demonstrated adaptability and ability to thrive in a fast-paced, global environment
- Proven technical competency in Clinical Data Management and continuous process improvement
- Working Environment Hybrid work environment, depending on business needs
Desired Qualifications
- Experience supporting Phase I–IV clinical trials is preferred
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