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Posted 21 days ago

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Clinical Data Associate II

Mexico CityOn-siteFull-time

AI Summary

Performs advanced clinical data cleaning and management tasks, resolving data discrepancies, generating queries, reviewing listings, and producing status reports in accordance with GCPs and SOPs.

About this role

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Data Assoc II – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Clinical Data Assoc II, you will perform advanced aspects of the data cleaning process with a high level of accuracy and in accordance with Good Clinical Practices (GCPs) and Standard Operating Procedures/Work Process Documents (SOPs/WPDs), to assess the safety and efficacy of investigational products and/or medical devices.

What You’ll Do:

• Identify, resolve, and update data discrepancies. Make changes to the data management database as required.
• Generate, track and resolve data clarifications and queries. May implement CRF design in identified graphic design package.
• Review data listings for accuracy and consistency of data. Analyze and resolve data validation and other data management reports.
• Produce project-specific status reports for CDM management and for clients on a regular basis.
• Perform data management activities such as Serious Adverse Event and Third Party Vendor reconciliations as well as Data Listing reviews.

Education and Experience Requirements:
• High / Secondary school diploma or equivalent and relevant formal academic/vocational qualification
• Technical positions may require a certificate
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 3 years).
In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
• Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
• Strong attention to detail and skill with numbers and ability to use interactive computer programs
• Good written and verbal communication skills and a strong command of the English language and grammar
• Good organizational and analytical/problem-solving skills
• Ability to work productively with moderate supervision
• Ability to maintain a high degree of confidentiality with clinical data and clients' proprietary data
• Strong customer focus and excellent interpersonal skills.
• Proven flexibility, adaptability, and ability to work in a team environment or independently as needed
• Must demonstrate good judgment in making decisions
• Knowledge of medical/clinical trial terminology
• Understands project protocol and Data Validation Manual


Working Conditions and Environment:


• Work is performed in an office or clinical environment with exposure to electrical office equipment.


Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

Skills

Clinical Trial Management SystemsCRF DesignData Listing ReviewsData Management DatabaseData Management SoftwareData Validation ManualData Validation ReportsExcelGood Clinical Practices (GCPs)Interactive Computer ProgramsMedical/Clinical Trial TerminologyMicrosoft OfficeOutlookProject Status ReportingSerious Adverse Event ReconciliationStandard Operating Procedures (SOPs)Third Party Vendor ReconciliationWord

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