Clinical Data Associate
Location: Bangalore, KA, India – Ground Floor, Unit 1, Block E, Helios Business Park
Job ID: 3430
Schedule: Full-time
Company Overview
Novotech is a global full-service Clinical Contract Research Organization (CRO) headquartered in Sydney, Australia.
34 offices across Asia-Pacific, North America, and Europe.
Employs over 3,000 staff with 5,000+ site partnerships.
Provides end-to-end clinical development services:
Feasibility assessments
Ethics committee & regulatory submissions
Data management and statistical analysis
Medical monitoring and safety solutions
Central lab services
Report writing to ICH requirements
Project and vendor management
Certified with ISO 27001 (Information Security) and ISO 9001 (Quality Management).
Role Overview
The Clinical Data Associate (CDA) provides in-house data entry and administrative support to clinical data management projects. The role supports Clinical Data Managers (CDMs) and ensures quality standards in accordance with GCDMP guidelines, SOPs, ICH-GCP, and local regulatory requirements.
Key Responsibilities
Data Management Support
Enter clinical trial data using Clinical Data Management software.
Assist CDMs in reviewing and raising data queries with sponsors/monitoring staff.
Track CRF pages received/entered and data queries sent/received.
Support database testing and edit check testing.
Assist with data cleaning, validation, and reconciliation of external data.
Develop and maintain good communication and working relationships with lead CDMs.
Assist in reporting, listings, and other outputs during projects.
Coordinate coding and electronic data transfers and resolve discrepancies.
Develop/update systems to track study progress (e.g., Novotrak, CRF & query flow, safety reports).
Participate in project meetings and assist with agenda/minute writing.
Administrative & Operational Support
Adhere to company Quality Policy and SOPs.
Provide general administrative support to the Data Management team.
Actively contribute to process improvement initiatives.
Represent Novotech professionally in all external communications.
Participate in industry conferences and professional forums for development and promotion.
Perform other tasks as assigned by Line Manager.
Qualifications & Experience
Graduate in Clinical or Life Sciences or relevant allied professions.
Minimum 2 years’ experience in research, pharmaceutical industry, or related field.
Desired Skills & Competencies
Strong attention to detail and organizational skills.
Knowledge of clinical trial data management and regulatory requirements.
Proficiency in Microsoft Office and data management tools.
Ability to work collaboratively in a team environment.
Strategic mindset with the ability to make proactive decisions.
Culture & Benefits
Inclusive work environment supporting gender equality, LGBTIQ+, disabilities, and caring responsibilities.
Flexible working options, paid parental leave, wellness programs, and professional development opportunities.
Work alongside empowered teams in a collaborative global organization.
Equal Opportunity Statement
Novotech is an Equal Employment Opportunity Employer committed to diversity and inclusion. Employment decisions are based on merit, qualifications, and business requirements without regard to race, religion, gender, age, sexual orientation, disability, or other protected characteristics.
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