Location: India / Global Opportunities
Job Role: Clinical Data Associate II (CDA II)
Industry: Clinical Research | Clinical Data Management | Pharmaceutical Industry
Experience Required: 2–5 Years Experience Required (Not for Freshers)
About the Role
A Clinical Data Associate II (CDA II) plays a crucial role in ensuring the accuracy, consistency, and integrity of clinical trial data within pharmaceutical, biotechnology, and CRO environments. This position is ideal for professionals looking to advance their career in Clinical Data Management (CDM), clinical research operations, and regulatory-compliant healthcare data processing.
The role involves managing clinical trial databases, reviewing case report forms (CRFs), resolving data discrepancies, and supporting high-quality clinical research activities in compliance with global regulatory standards including ICH-GCP, FDA, EMA, and CDISC guidelines.
Key Responsibilities
Perform clinical data review, validation, and discrepancy management activities
Review Case Report Forms (CRFs/eCRFs) for completeness and accuracy
Generate and resolve data queries in collaboration with cross-functional clinical teams
Ensure data quality and consistency across clinical trial databases
Support database lock activities and clinical study timelines
Work closely with Clinical Data Managers, Biostatistics teams, Clinical Operations, and Medical Review teams
Conduct data cleaning and quality control checks according to SOPs and regulatory standards
Assist in maintaining study documentation and audit readiness
Ensure compliance with ICH-GCP, FDA, EMA, and internal quality guidelines
Required Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Nursing, or related healthcare fields
2–5 years of experience in Clinical Data Management or Clinical Research
Strong understanding of CRF review, query management, and clinical trial workflows
Knowledge of EDC systems such as Medidata Rave, Oracle Clinical, Inform, or similar platforms
Familiarity with CDISC standards, GCP guidelines, and regulatory compliance
Excellent analytical, communication, and problem-solving skills
Preferred Skills
Experience working in CROs, pharmaceutical companies, or biotech organizations
Strong attention to detail and data accuracy
Ability to work in fast-paced global clinical trial environments
Knowledge of database lock and reconciliation activities
Exposure to clinical trial lifecycle and regulatory submissions
Why Choose a Career as CDA II?
Clinical Data Management is one of the fastest-growing domains in the global pharmaceutical and clinical research industry. A CDA II role provides strong career growth opportunities toward positions such as:
Clinical Data Manager
Senior Clinical Data Associate
Clinical Project Specialist
Data Review Scientist
Clinical Operations Professional
This role offers excellent exposure to international clinical trials, healthcare technology platforms, and regulatory-driven research processes.
Who Can Apply?
This opportunity is suitable for experienced Clinical Data Management professionals with 2–5 years of relevant industry experience. Freshers may explore entry-level opportunities such as Clinical Data Associate I, Clinical Trial Assistant, or Junior Clinical Research roles before transitioning into CDA II positions.
Apply Now
Explore more global Clinical Research, Pharmacovigilance, Regulatory Affairs, Medical Writing, and Clinical Data Management jobs at ThePharmaDaily.com — your trusted platform for pharmaceutical and healthcare career opportunities.
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