Novotech

About Novotech Novotech is the Asia-Pacific CRO designed for biotech, accelerating clinical development via cutting-edge technology to improve patient lives. Working in a fast-paced and adaptable environment, we strive to set the benchmark for both business and clinical trial performance across all clinical trial phases and therapeutic areas. Our people are critical in meeting organizational, an

About Novotech Novotech is the Asia-Pacific CRO designed for biotech, accelerating clinical development via cutting-edge technology to improve patient lives. Working in a fast-paced and adaptable environment, we strive to set the benchmark for both business and clinical trial performance across all clinical trial phases and therapeutic areas. Our people are critical in meeting organizational, an

About Novotech Novotech is the Asia-Pacific CRO designed for biotech, accelerating clinical development via cutting-edge technology to improve patient lives. Working in a fast-paced and adaptable environment, we strive to set the benchmark for both business and clinical trial performance across all clinical trial phases and therapeutic areas. Our people are critical in meeting organizational, an

Check test plans and liaise with Clinical Data Programmer and Data Analyst as to the number and nature of edit checks to be implemented in the EDC study DB versus other software tools. .Undertake all validation and testing activities, document test results and communicate to relevant stakeholders including Clinical Data Manager and Technical Designer. Update validation and test plans as required

Soft Skills: Ability to educate a non-technical audience about various security measure. Effective verbal and written communication skills. Excellent problem-solving and analytical skills. Responsibilities: The responsibilities will vary day to day and may include: Monitoring cyber threats, security risks and security controls: Identifying vulnerabilities in our current network. Developin

Organization Description Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services. It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned

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. Brief Position Description: The HR Analytics & Reporting Specialist is pr

Clinical Data Manager is responsible for planning, conducting and managing of all aspects of data management for a clinical trial according to the client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements and SOPs. 1. Determination of project feasibility from a data management perspective. Understand the requirements of the project agre

Setting up SVT in CTMS 1.Understand protocol schedule of events and initiate SVT setup discussion with study PM/LCRA 2.Discuss and analyze multiple payee option requirement during initial setup including withholding amount. 3.Analyze and assess SVT setup requirement based on study type (simple/complex/cohort). 4.Setup Master/Site specific SVT templates in CTMS and ensure accurate templa

Knowledge and experience in international drug safety-regulatory reporting obligations and compliance, coding applications, case processing, safety processes and tools is preferred. Good knowledge of medical terminology, ability to write clear, concise, unambiguous medical text is required. Ability to acquire knowledge in different disease and therapeutic areas, fluency in English, ability to

Understand which Clinical Trial Agreement template is used by countries in Novotech geographies; and where site specific templates are applicable. Independent review and amendment of Clinical Trial Agreements within agreed negotiation parameters and policies. Escalate Clinical Trial Agreements outside of agreed negotiation parameters and policies as required; and obtain guidance and approval by L

Provide timely support for medical assessment of initial case triage and also assist in reviewing medical information queries pertaining to ICSRs. • Able to properly rank event based on seriousness criteria, labeling and causality assessment • Causality assessment for all events based on WHO algorithm and ICH guidelines also taking into consideration vendor conventions specific for different ther