About The Role:
The Clinical Lead Analyst (CLA) works collaboratively with Clinical Lead in managing clinical delivery of the project, by closely monitoring the clinical deliverables, project performance & schedule, compliance, risks, quality of the project.
Minimum Qualifications & Experience:
- Requires minimum of 3 years of work experience, with minimum 1.5 years of relevant experience in a clinical research organization or equivalent role.
- Basic knowledge of applicable research and regulatory requirements, i.e. International Conference on Harmonization - Good Clinical Practice and relevant local laws, regulations, and guidelines.
- Knowledge of Microsoft Applications including but not limited to Microsoft Excel, Word and PowerPoint.
- Exposure to basic data analysis required for projects during start-up, maintenance and close outs.
- Certification course in Clinical Research will be an added advantage.
Responsibilities:
- CLA provides analytics, reports, status update, risk alerts and required mitigation recommendations to the Clinical Lead and rest of the clinical team throughout the lifecycle of the project.
- CLA supports the Clinical Lead with tools to ensure efficient oversight of clinical deliverables of a project and to ensure adherence to project scope (clinical), protocol, SOPs, applicable regulations, and study plans (CMAP, PD management plan, recruitment plan, IQRMP, IP management, etc.) focusing on applications, analytics, therapeutics, regional requirements, blinding processes, project milestones, and quality perspectives.
- Conducts periodic review of project KPIs, shares status/analysis, follows up for open action items in accordance to clinical lead s directions.
- Monitors site-performance parameters at study level and makes recommendations for timely corrective actions under the guidance of Clinical Lead.
- Evaluates the quality of study processes (clinical) and supports the Clinical in monitoring quality of conduct of the protocol and adherence to applicable regulations.
- Establishes and maintains effective project/site-level communications with relevant stakeholders (for clinical) as delegated by Clinical Lead.
- Ensures compliance on study databases (Clinical Trial Management System (CTMS), Interactive Web Response System (IWRS), Electronic Data Capture (EDC) etc.)
- Supports Clinical Lead in protocol deviation management.
- Performs assigned administrative tasks to support Clinical Lead with project execution.
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.
Minimum Qualifications & Experience:
- Minimum bachelor s degree in Life science or related field.
- Proven experience (1-2 years) in import and export operations, preferably in a similar role.
- Strong knowledge of import and export regulations, customs procedures, and international trade practices.
- Excellent organizational and time management skills to handle multiple shipments and prioritize tasks effectively.
- Attention to detail to ensure accuracy in document preparation and compliance with regulations.
- Strong communication and interpersonal skills to collaborate with internal teams and external stakeholders.
- Proficiency in using MS Office applications.
- Problem-solving skills to address issues related to customs clearances, shipping delays, and trade compliance requirements.
- Ability to work under pressure and meet deadlines in a fast-paced environment.
Responsibilities:
- Ensure compliance: Monitor and ensure adherence to import and export regulations, including customs laws, licensing requirements, and trade agreements if applicable.
- Documentation management: Prepare and review import and export documentation, including invoices, packing lists, bills of lading, and customs declarations to ensure accuracy and compliance.
- Coordinate shipments: Collaborate with freight forwarders and logistics providers to arrange transportation, track shipments, and manage customs clearance processes.
- Customs clearance: Liaise with customs authorities to ensure smooth clearance of imported and exported goods, resolve any issues that arise, and address customs inquiries or audits.
- Inventory management: Monitor inventory levels and coordinate with internal teams to ensure an efficient supply chain, including optimizing lead times and managing stock levels to meet customer demands.
- Coordinate with vendor: Collaborate with vendor to align import and export activities with business goals and objectives. Provide documents to vendor for customs clearance.
- Coordinate with internal departments: Collaborate with study team to align import and export activities with business goals and objectives.
- Tariff classification: Accurately classify imported and exported goods according to customs tariff codes to determine duty rates and ensure compliance with trade regulations.
- Maintain records: Keep comprehensive records of all import and export transactions, including shipping documents, licenses, and compliance documentation for audit purposes.
- Stay up-to-date: Stay informed about changes in international trade regulations, tariffs, and customs requirements to ensure compliance and adapt import/export processes accordingly.
- Provide invoice of vendor s service fee of import and export to study team for reimbursement.
