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Clin Data Assoc Ii

Thermo Fisher Scientific
Thermo Fisher Scientific
1.6-3 years
Not Disclosed
10 Jan. 20, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Clinical Data Associate II (CDA II – FSP)

Company: Thermo Fisher Scientific – PPD Clinical Research Services
Location: Remote, India
Job Type: Full-Time / Fully Remote
Category: Clinical Research / Clinical Data Management
Experience Required: 1.6 – 3 years in Clinical Data Management


Job Overview

Thermo Fisher Scientific’s PPD Clinical Research Services is seeking a Clinical Data Associate II (CDA II) to join our global FSP team. This role is responsible for advanced data review, cleaning, and validation activities, ensuring data integrity, accuracy, and inspection readiness across clinical studies.

As a CDA II, you will manage complex queries, perform SAE and third-party reconciliations, review data listings, contribute to CRF design, and support database updates. You will collaborate with cross-functional teams to produce analysis-ready datasets that support accurate safety and efficacy assessments.


Key Responsibilities

Data Management & Validation

  • Identify, investigate, and resolve data discrepancies, ensuring timely updates in the CDM database

  • Generate, track, and resolve data clarifications and queries

  • Conduct data listings and validation output reviews for accuracy and completeness

  • Perform serious adverse event (SAE) and third-party vendor reconciliations

System & Process Support

  • Assist in CRF design and database updates using electronic data capture (EDC) systems

  • Contribute to the development and implementation of project-specific CDM processes

  • Ensure compliance with GCP, SOPs/WPDs, and client-specific requirements

Reporting & Collaboration

  • Produce project-specific status reports for management and client stakeholders

  • Partner with cross-functional teams to resolve issues, mitigate risks, and maintain study timelines

  • Maintain high standards for data quality and inspection-readiness


Qualifications & Experience

Education:

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field

Experience:

  • 1.6 – 3 years of relevant Clinical Data Management experience

  • Hands-on experience with RAVE or Veeva EDC systems

  • Knowledge of clinical trial data workflows, GCP guidelines, and regulatory requirements

Skills & Competencies:

  • Strong attention to detail with excellent analytical and problem-solving skills

  • Proficiency in clinical trial terminology and data management processes

  • Effective verbal and written communication skills with professional command of English

  • Ability to work independently and collaboratively in a remote, global environment

  • Strong organizational skills, ability to prioritize tasks, and maintain confidentiality

  • Flexibility to adapt to changing project needs and deadlines


Career Growth & Global Exposure

  • Work on international clinical studies across multiple phases and therapeutic areas

  • Gain exposure to modern CDM workflows, AI-enabled clinical trial technologies, and global study operations

  • Career progression opportunities along Clinical Data Management tracks (Senior CDA, CDTL, CDM PM) or transition into Data Standards/Programming


Why Join Thermo Fisher Scientific – PPD Clinical Research Services

  • Global Exposure: Collaborate with international teams, CROs, vendors, and country operations

  • End-to-End Ownership: Contribute to every stage of study delivery, from database setup to study close-out

  • Career Development: Structured mentorship, stretch assignments, and FSP-focused growth pathways

  • Innovation & Technology: Work with EDC systems and AI-driven clinical trial platforms

  • Collaborative Environment: Join a high-performance team focused on quality, operational excellence, and patient impact