Clin Data Associate II

 Posted a month ago
  
 India
  
2-5 years experience
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AI Summary

Perform advanced data cleaning and resolve discrepancies in accordance with GCP and SOPs to assess product safety and efficacy. Generate status reports and perform reconciliations for Serious Adverse Events and third-party vendors.

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:

  • Bachelor’s degree or equivalent in a relevant field
  • Minimum 4+ years of experience in clinical data management
  • Hands-on experience with RAVE and/or Veeva EDC systems


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 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 client's 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.
• Occasional drives to site locations. Potential Occasional travel required.

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.

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