Clinical Data Associate II (CDA II) – Fully Remote
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Clinical Data Management
Job ID: R-01338260
Work Mode: Fully Remote
Work Schedule: Standard (Monday to Friday)
About the Role
We are seeking a highly motivated Clinical Data Associate II (CDA II) to join a leading global clinical research organization supporting large-scale international clinical trials. This role plays a critical part in ensuring data quality, integrity, and regulatory compliance across clinical studies conducted for top pharmaceutical and biotechnology sponsors worldwide.
As a CDA II, you will be responsible for advanced clinical data review, query management, reconciliation activities, and database quality control, contributing directly to inspection-ready, analysis-quality datasets that support accurate safety and efficacy evaluations.
Key Responsibilities
Perform comprehensive data review, discrepancy identification, and resolution in accordance with GCP, SOPs, and study-specific requirements
Generate, track, and resolve data queries to ensure timely database cleaning and lock readiness
Review clinical data listings, validation outputs, and data management reports for accuracy and consistency
Conduct Serious Adverse Event (SAE) reconciliations and third-party vendor data reconciliations
Support CRF design implementation and database updates using approved graphic design tools
Prepare and deliver regular project-specific data status reports for internal stakeholders and clients
Collaborate cross-functionally with clinical operations, biostatistics, and data science teams to proactively manage risks and issues
Maintain strict confidentiality of clinical and proprietary sponsor data
Education and Experience Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, or a related discipline
Minimum 1.6 to 3 years of hands-on experience in Clinical Data Management or Clinical Research
Proven working experience with RAVE and/or Veeva EDC systems
Prior exposure to global clinical trials and remote study teams is preferred
Required Knowledge, Skills, and Competencies
Strong understanding of clinical trial processes, medical terminology, and data validation principles
Demonstrated ability to work in compliance with global regulatory standards and client expectations
High attention to detail with strong analytical and problem-solving skills
Proficiency in interactive clinical data systems and reporting tools
Excellent written and verbal communication skills with strong command of English
Ability to work independently with moderate supervision while meeting timelines
Strong interpersonal skills with a customer-focused mindset
Proven adaptability and ability to perform effectively in a fast-paced, global environment
Working Conditions
Work is primarily performed in a remote office environment
Occasional travel to clinical sites or meetings may be required based on project needs
Career Development and Growth Opportunities
This position supports a dedicated Functional Service Provider (FSP) model for a globally recognized biopharmaceutical sponsor with a strong legacy in specialty medicines, vaccines, and scientific innovation. As part of this engagement, you will collaborate with global data science and clinical teams on high-visibility, complex studies.
The FSP model offers structured career progression, continuous learning opportunities, mentorship, and exposure to advanced clinical trial technologies, including AI-enabled data management workflows. Career paths may include progression to Senior Clinical Data Management roles, Clinical Data Team Lead positions, or transitions into Data Standards and Clinical Programming functions.
Why Join Us
Work on international, multi-phase clinical trials across diverse therapeutic areas
Gain end-to-end exposure from study set-up to database lock and close-out
Strengthen global project management, data quality, and risk management capabilities
Build future-ready skills in modern clinical data management and emerging digital trial platforms
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the global leader in serving science, with annual revenues exceeding USD 44 billion. With a mission to enable customers to make the world healthier, cleaner, and safer, the organization supports life sciences research, clinical development, diagnostics, and pharmaceutical manufacturing through industry-leading brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Patheon, and Fisher Scientific.
Thermo Fisher Scientific is an equal opportunity employer and is committed to fostering a diverse and inclusive workforce worldwide.
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