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Clinical Data Associate Ii

2+ years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Remote Education: Bachelor’s degree or equivalent formal academic qualification Combination of education, training, and relevant experience may be considered Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Data Associate II

📍 Location: Bangalore, Karnataka, India
🆔 Job ID: R-01324178
🕒 Job Type: Full-time
🏢 Category: Clinical Research
🌐 Remote: Fully Remote
🗓 Work Schedule: Second Shift (1:00 PM – 10:00 PM IST)
⚠️ Environment: Adherence to Good Manufacturing Practices (GMP) safety standards


About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our mission is to make the world healthier, cleaner, and safer. Through innovative technologies and services across industry-leading brands — Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD — we empower our customers to solve complex challenges in life sciences, diagnostics, and therapeutics.


About Trialmed

This position is with Trialmed, the global site network and early-phase clinical research division of PPD, Thermo Fisher Scientific's clinical research business. Our Clinical Research team is committed to accelerating cures by providing top-tier scientific and clinical expertise to support the development of life-changing therapies.


Role Overview

As a Clinical Data Associate II (CDA II), you will support data management functions across early-phase clinical studies. You will play a critical role in data cleaning, validation, reconciliation, and query resolution—ensuring the quality and accuracy of clinical trial data. You’ll work cross-functionally in a fast-paced environment, applying your technical, analytical, and project coordination skills.


Key Responsibilities

📊 Data Management

  • Identify and resolve discrepancies in the clinical data management database

  • Generate, track, and manage data clarifications and queries

  • Review data listings for accuracy and consistency

  • Perform SAE and third-party vendor reconciliations

  • Support data listing reviews and CRF design implementation

🧪 Data Cleaning & Validation

  • Perform advanced data cleaning activities in compliance with GCPs and SOPs

  • Evaluate the safety and efficacy of investigational products/devices through data review

  • Analyze and resolve complex data validation issues

  • Produce status reports for CDM management and clients

🤝 Team Collaboration

  • Work cross-functionally and independently to resolve project issues

  • Provide input on project protocols and Data Validation Manual (DVM)

  • May act as a facilitator or team lead on assigned projects

  • Prepare and deliver internal and external communications with professionalism and tact


Qualifications

🎓 Education

  • Bachelor’s degree or equivalent formal academic qualification

  • Combination of education, training, and relevant experience may be considered

📈 Experience

  • Minimum 2+ years of experience in clinical data management or a related field


Skills & Competencies

💻 Technical Proficiency

  • Proficient with EDC systems, especially Medidata Rave and Veeva Vault

  • Familiar with eTMF and good documentation practices

  • Solid command of Microsoft Office tools and interactive software systems

🧠 Knowledge & Abilities

  • Understanding of clinical trial terminology, data validation processes, and protocols

  • Ability to manage confidential data with discretion

  • Skilled in analytical thinking, problem-solving, and time management

  • Familiarity with Generative AI tools is a plus

  • Adaptable, organized, and able to work independently or in teams

  • Strong interpersonal and customer focus skills

  • Excellent written and verbal English communication


Work Environment

  • Flexible work options: Office, remote, or hybrid

  • Second shift: 1:00 PM to 10:00 PM IST


Accessibility & Accommodations

We are committed to ensuring equal opportunity for individuals with disabilities. Reasonable accommodations will be provided throughout the application, interview, and employment process.


Equal Opportunity Statement

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, disability, age, veteran status, or any other protected status.


Why Join Us?

  • Work on high-impact clinical trials that drive life-saving treatments

  • Be part of a global leader in science and innovation

  • Thrive in a flexible, inclusive, and growth-oriented work environment

  • Join a mission-driven team focused on making a real difference in healthcare

🔗 Learn more at: www.thermofisher.com