Biometrics Administrator (Compliance) Job at Novotech in India | Clinical Research Role – Apply Now
Are you passionate about regulatory compliance, data integrity, and clinical research? Do you have a sharp eye for detail and a drive to ensure systems run flawlessly in a highly regulated environment? Join Novotech as a Biometrics Administrator (Compliance Support Specialist) and play a pivotal role in supporting global clinical trials that shape the future of medicine. This is your chance to work with one of the world’s leading Contract Research Organizations (CROs), where innovation, quality, and compliance come together to accelerate better health outcomes.
About Novotech
Novotech is a leading full-service clinical Contract Research Organization (CRO) headquartered in Sydney, Australia, with a strong presence across Asia-Pacific, North America, and Europe. We specialize in providing clinical development services for biotech and pharmaceutical companies, offering deep expertise across all trial phases and therapeutic areas. With over three decades of experience, Novotech has built a reputation for operational excellence, data-driven decision-making, and regulatory expertise. Our 34 global offices are strategically positioned to offer local insight with global impact. We pride ourselves on delivering high-quality, cost-effective, and timely clinical trial solutions, underpinned by robust information security and regulatory
compliance frameworks. At Novotech, we don’t just manage trials—we build trusted partnerships that contribute to life-changing treatments for patients worldwide.Biometrics Administrator (Compliance) Job Details:
Job Posting: Biometrics Administrator (Compliance)
Location: India
Biometrics Administrator (Compliance) Job Description
About the role:
We are seeking a Biometrics Administrator (Compliance Support Specialist) to assist in the management of system reviews, validation, and regulatory compliance within our Biometrics team. This role will involve performing compliance activities, supporting system, departmental and external audits, maintaining documenta-tion, and ensuring adherence to regulatory requirements such as GxP, 21 CFR Part 11, and data integrity guidelines.
The ideal candidate will have strong organizational skills, technical apptitude, attention to detail, and an understanding of regulatory frameworks relevant to clinical research and data management systems.
Responsibilities of Biometrics Administrator (Compliance) Job:
1. Biometrics Compliance & System Review Support
- Assist in managing system reviews for Biometrics teams, ensuring compliance with GxP, 21 CFR Part 11, ICH E6 (R2/R3), and other applicable regulations.
- Support system validation activities, including system release monitoring and change management, CSV reviews and compliance checks.
- Track and document system performance, issues, and remediation efforts.
- Coordinate vendor assessments and system qualification activities where applicable.
- Support Departmental Non-Compliance and Quality Issue Management (Identification, Tracking and reporting)
- Support the assessment of preventative actions.
2. Documentation & Record Keeping
- Maintain and update validation documentation, and compliance records.
- Assist in preparing audit responses, risk assessments, and CAPA (Corrective and Preventive Action) documentation.
- Ensure appropriate documentation of system access controls, data integrity, and audit trails.
3. Regulatory & Quality Assurance Support
- Collaborate with Quality Assurance (QA) and IT teams to ensure adherence to compliance requirements.
- Support internal and external audits by providing documentation and facilitating audit requests.
- Monitor regulatory updates and industry best practices
- Perform Quality reviews to ensure study team compliance with internal processes and best practices.
- Work closely with Data Management, Biostatistics, IT, and QA teams to support compliance efforts.
- Assist in organizing compliance training.
Required Qualifications & Experience for Biometrics Administrator (Compliance) Job
- Education: Bachelor’s degree in Life Sciences, Computer Science, Regulatory Affairs, or a related field (or equivalent experience).
- Experience:
- 1-3 years of experience in compliance support or regulatory affairs or data management within clinical research, ideally working in a CRO.
- We encourage applicants with a technical background in programming and/or software testing who are interested in compliance.
- Familiarity with GxP, 21 CFR Part 11, ICH E6 (R2), ISO 27001, and data integrity principles.
- Experience with system validation (CSV), audit preparation, and documentation management is desirable.
Technical Skills for Biometrics Administrator (Compliance) Job
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, SharePoint)
- Understanding of clinical trial data systems, EDC, and statistical analysis software
Soft Skills
- Excellent attention to detail, organizational skills, and problem-solving abilities.
- Strong communication and collaboration skills, with the ability to work cross-functionally.
- Ability to manage multiple priorities in a fast-paced, regulated environment.
Keywords: Biometrics Administrator, Compliance, Novotech, Clinical Research, CRO, Regulatory Compliance, Data Management, GxP, 21 CFR Part 11, Biometrics Administrator (Compliance) Job
