Exciting Clinical Data Associate Job at Novotech offering data management responsibilities, growth opportunities, and a supportive work environment.
Introduction
Novotech, a leading global full-service Contract Research Organization (CRO), is inviting applications for the position of Clinical Data Associate in India. This role is ideal for candidates passionate about clinical research, data management, and contributing to the progress of global biotech and pharmaceutical studies. Recognized for delivering world-class clinical trial services, Novotech offers a dynamic workplace that encourages professional growth, collaboration, and continuous learning. Clinical Data Associate Job at Novotech
The Clinical Data Associate will support data management operations across various clinical studies, ensuring accuracy, compliance, and quality according to industry standards. The role includes handling clinical trial data, coordinating with project teams, assisting Clinical Data Managers (CDMs), and participating in process improvement initiatives. With Novotech’s global presence and over 3000 employees worldwide, this opportunity provides a solid platform for career development in the clinical research industry. Clinical Data Associate Job at Novotech
About the Role
The Clinical Data Associate is responsible for supporting the daily data management activities for ongoing clinical studies. This includes accurate data entry, validation, query management, database checks, and assisting CDMs in ensuring data quality throughout the project lifecycle. The role aligns with Novotech’s commitment to delivering high-quality clinical trial services according to ICH-GCP, GCDMP guidelines, and standard operating procedures (SOPs). Clinical Data Associate Job at Novotech
This position reports directly to the Biometrics Project Manager and involves close collaboration with lead CDMs, project teams, sponsors, and monitoring staff to ensure seamless data flow and timely project execution. Clinical Data Associate Job at Novotech
Minimum Qualifications and Experience
Applicants for the Clinical Data Associate position must meet the following requirements:
- Bachelor’s degree in clinical research, life sciences, or a related field.
- Candidates with relevant experience in allied professions may also be considered.
- Minimum 2 years of experience in the research, pharmaceutical, biotechnology, or healthcare industry.
- Strong understanding of clinical trials, data management processes, and industry regulations.
- Working knowledge of clinical data management systems will be an advantage.
Key Responsibilities
As a Clinical Data Associate at Novotech, your responsibilities will include: Clinical Data Associate Job at Novotech
1. Clinical Trial Data Entry
Accurate and timely data entry using approved Clinical Data Management (CDM) software systems. Ensuring all entries comply with study guidelines and SOPs.
2. Data Query Review and Management
Assisting in reviewing data queries to be raised with sponsor companies or monitoring teams. This includes identifying discrepancies, inconsistencies, or missing data and ensuring that all queries are appropriately tracked and resolved.
3. Tracking CRF Pages and Queries
Maintaining up-to-date records of CRF (Case Report Form) pages received, entered, and pending. Managing data queries sent, received, and closed within defined timelines.
4. Database Testing and Edit Checks
Supporting CDMs in database setup, testing processes, and edit-check testing to ensure accurate system behavior before data entry begins.
5. Data Cleaning and Validation
Assisting in the data cleaning process, performing validations, and supporting reconciliation of external data sources such as laboratory reports, imaging data, and safety data.
6. Communication with Lead CDMs
Developing and maintaining clear, professional communication channels with lead Clinical Data Managers and project teams.
7. Report and Listing Preparation
Supporting CDMs in creating detailed reports, listings, and other project-specific outputs required throughout the study lifecycle.
8. Handling Coding and Electronic Data Transfers
Coordinating coding activities for medical terms, ensuring data transfers are accurate, and resolving discrepancies arising from external sources.
9. Study Tracking System Updates
Assisting with the development and ongoing updates of tracking systems such as Novotrak, CRF flow logs, safety report tracking, and other study-related documentation.
10. Participation in Project Meetings
Attending internal and external project meetings as required, ensuring accurate documentation, including agendas and meeting minutes.
11. Administrative Support
Providing administrative assistance to the Data Management Department based on the needs of the Clinical Data Manager.
12. Adherence to Quality Policies
Following Novotech’s Quality Policy and procedures to ensure all tasks meet regulatory and company-specific standards.
13. Contribution to Process Improvement
Supporting data management process improvements, contributing to standardization and efficiency enhancement initiatives.
14. Representation of Novotech
Ensuring all communication with external stakeholders reflects Novotech’s values, professionalism, and commitment to service excellence.
15. Professional Participation in Industry Forums
Participating in conferences, professional associations, and external training sessions to enhance skills and promote Novotech’s presence in the clinical research industry.
16. Additional Responsibilities
Performing additional tasks assigned by the Line Manager or Clinical Data Manager to support the Data Management team’s smooth functioning.
Clinical Data Associate Job at Novotech
Why Join Novotech?
Novotech is recognized for its employee-friendly policies, commitment to workplace equality, and focus on professional development. The company offers a supportive and dynamic environment where employees are encouraged to grow and excel. Clinical Data Associate Job at Novotech
Key Benefits Include:
- Flexible working options
- Paid parental leave for both parents
- Supportive leave entitlements and wellness programs
- Inclusive workplace environment
- Opportunities for career advancement
- Access to global teams and international exposure
- Participation in advanced clinical research projects
Novotech embraces diversity and encourages applicants from all backgrounds, including individuals with disabilities, those with caring responsibilities, and those who identify as LGBTIQ+. Clinical Data Associate Job at Novotech
About Novotech
Novotech is a global full-service Contract Research Organization (CRO) with headquarters in Sydney, Australia. The company operates across Asia-Pacific, North America, and Europe with over 34 offices and more than 3000 employees. Clinical Data Associate Job at Novotech
The organization specializes in providing end-to-end clinical development services across all clinical trial phases. Its offerings include: Clinical Data Associate Job at Novotech
- Feasibility assessments
- Regulatory and ethics submissions
- Data management and statistical analysis
- Medical monitoring and safety solutions
- Central lab services
- ICH-compliant report writing
- Project and vendor management
Novotech is ISO 27001 and ISO 9001 certified, ensuring top-level security and quality standards for client data and clinical operations. Clinical Data Associate Job at Novotech
How to Apply
Interested candidates can apply for the Clinical Data Associate position through the official Novotech careers page. Visit the job listing, fill in the required details, upload your resume, and submit your application.
Location: Ground Floor, Unit 1, Block E, Helios Business Park, Bangalore, 560103, India.
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