Biometrics Administrator (Compliance)

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, attention to detail, and an understanding of regulatory frameworks relevant to clinical research and data management systems.

Responsibilities:

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

• 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.
• 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

• 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.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

Responsibilities

• Provide general administrative support, including project filing and support for the Biometrics Management team.
• Schedule meetings and assist with agenda/minute writing and distribution for project team meetings as delegated by the Line Manager.
• Assist with drafting essential non-project documents.
• Set up and maintain systems to track study progress (e.g., project status reports, contracts, vendor invoices). Provide updates to Biometrics Management as required.
• Receive, process, obtain approval, and track all vendor and non-vendor invoices for the Biometrics department.
• Track and report on the progress and status of all Biometrics projects with guidance from the Line Manager and biometrics team.
• Assist with project and department financial analysis and reporting under the Line Manager's guidance.
• Perform quality reviews on study documentation.
• Understand Novotech's responsibilities as a service provider in the pharmaceutical industry and ensure professional communication with external parties.
• Additional ad hoc responsibilities as assigned by the Line Manager.

Minimum Qualifications & Experience:

• Minimum Bachelor’s Degree with a major in a business or commerce discipline would be highly regarded.
• 1-2 years’ experience in-house supporting a busy operational team.
• Personal integrity and respect for confidential information.
• Attention to detail, ability to use initiative, and a self-starter able to work autonomously. Self-organized and process-oriented.
• Flexibility and ability to adapt in a dynamic environment.
• Excellent written and oral communication skills.
• Willingness to learn new technology and applications. Advanced skills in MS Application Suite including Word and Excel.
• Knowledge of SharePoint, Power BI, and reporting applications would be an advantage.
• Multi-tasking skills under superseding/overlapping priorities.

Novotech is a global full-service clinical Contract Research Organization (CRO).

Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.