Position: Clinical Data Associate I
Location: Bangalore, India
Job Category: Data Management
Role Overview:
The Clinical Data Associate I will support day-to-day operations of data management projects. This includes providing in-house data entry support, assisting in data validation, and providing administrative support to Clinical Data Managers (CDMs), in alignment with GCDMP guidelines, local regulatory requirements, and Novotech/Client SOPs.
Key Responsibilities:
The Clinical Data Associate I will be involved in the following:
Data Entry: Enter clinical trial data into Clinical Data Management (CDM) software.
Data Queries: Assist in the review and resolution of data queries raised by sponsor companies/monitoring staff.
Tracking: Track CRF pages received, data queries sent/received, and data entered.
Database Support: Assist with database testing and the testing of edit checks.
Data Cleaning/Validation: Support data cleaning, validation, and reconciliation of external data sources.
Reporting: Assist CDM in generating reports, listings, and other project outputs.
Study Progress: Help maintain systems to track study progress, including safety reports and Novotrak updates.
Meetings and Documentation: Attend project meetings and assist with writing agendas and minutes for data management teams.
Administration: Provide general administrative support to the Data Management team as required.
Professional Development: Participate in professional forums, conferences, and associations for development and promoting Novotech's image.
Process Improvement: Actively contribute to company process improvement initiatives.
Minimum Qualifications & Experience:
Education:
A graduate degree in a clinical or life sciences-related field.
Relevant experience/qualifications in allied professions may also be considered.
Experience:
At least 6 months to 1 year of experience in research, the pharmaceutical industry, or a related field.
Desired Skills & Competencies
Strong understanding of clinical data management, data entry, and validation processes.
Ability to use Clinical Data Management software.
Knowledge of GCDMP, ICH-GCP, and relevant regulatory requirements.
Effective communication skills to collaborate with project teams and stakeholders.
Time management skills, with the ability to manage multiple tasks efficiently.
About Novotech:
Novotech is a global, full-service Clinical Contract Research Organization (CRO) offering comprehensive services across all clinical trial phases and therapeutic areas. Headquartered in Sydney, Australia, Novotech has 34 offices across the Asia-Pacific, North America, and Europe. We are committed to delivering high-quality clinical development services, with a focus on ISO 27001 and ISO 9001 certifications for IT security and quality.
Employee Benefits:
At Novotech, we provide a supportive and inclusive work environment, with benefits such as:
Flexible working options.
Paid parental leave for both parents.
Wellness programs and ongoing development opportunities.
We support diversity in the workplace and encourage applications from all backgrounds, including LGBTIQ+ individuals, people with disabilities, and those with caregiving responsibilities.
Application Details:
Location: Ground Floor, Unit 1, Block E, Helios Business Park, Bangalore, 560103, India
Job Schedule: Full Time
Apply By: 28th February 2025
For more details or to apply, click on Apply Now and follow the application process.
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