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Ciudad de México, México
Hybrid
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. Over the past five years, we have partnered with the world's top 50 pharmaceutical companies and more than 750 biotechnology organizations, supporting over 2,700 clinical trials across more than 100 countries.
As a Senior Clinical Data Associate, you will play a critical role in ensuring the quality, integrity, and reliability of clinical trial data. You will independently manage key Clinical Data Management activities across multiple studies, collaborating with cross-functional teams and clients to ensure timely, high-quality study delivery. Your work will directly support the evaluation of investigational products and medical devices, contributing to the development of innovative therapies that improve patients' lives.
Support study startup activities, including database design review, User Acceptance Testing (UAT), and Data Validation Manual (DVM) development, as applicable.
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.
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.
Experience supporting Phase I–IV clinical trials is preferred.
Equivalent combinations of education, training, and directly related experience will also be considered.
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.
Experience using Electronic Data Capture (EDC) systems such as Medidata Rave, Inform, Veeva CDMS, Oracle InForm, or equivalent platforms.
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.
Customer-focused mindset with a commitment to operational excellence.
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.
Hybrid work environment, depending on business needs.
At Thermo Fisher Scientific, you'll join a global organization committed to scientific innovation, operational excellence, and improving patient outcomes. We invest in our people by providing meaningful career development opportunities, exposure to cutting-edge clinical research, and the chance to collaborate with industry-leading experts worldwide.
If you're looking for a role where your expertise will influence the success of global clinical trials while continuing to grow your career, we'd love to hear from you.
Join our team and help accelerate the delivery of life-changing therapies to patients worldwide. Apply today.