Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Are you enthusiastic about understanding Clinical Operations and bringing attention to key project management challenges? Then you could be our new Clinical Development Centre (CDC) Trial Manager. Apply now for a life-changing career! About the department The Clinical, Medical, and Regulatory (CMR) department is one of the key functions that enable the business strategy through the effective execution of functional goals, in the areas of Clinical Research, Medical Affairs and Regulatory. This full-time permanent position is based in Kuala Lumpur and reports directly to the Clinical Operations Manager. The position As a CDC Trial Manager, you will be the main liable person for making sure that deliverables are met as per project timelines, within budget and complying with protocol, country regulatory requirements, Helsinki Declaration, GCP (Good Clinical Practice) and Novo Nordisk SOPs (Standard Operating Procedures). Key responsibilities include: Driving assigned clinical trials from the feasibility to Clinical trial reporting. Manage activities including planning, site selection, Ethics committee and health authority submissions, starting-up trial sites and organizing investigator meetings. Training site staff, CRAs (Clinical Research Associates), CTAs (Clinical Trial Administrators), start-up teams about the protocol and other protocol related information, providing operational and therapeutic expertise to the CDC project team, achieve deliverables (including recruitments) within timelines and in accordance with scientific, quality, and regulatory requirements. Ensure effective communication of all trial/project related issues between Headquarters, CDC, the region, and other Internal/external stakeholders. In-charge of representing CDC countries in relevant study meetings and organizing these meetings: Trial Squad Meetings Monitor meetings, Investigator meetings and Study Result meetings. Review and customisations of all trial related documents as relevant, coordinate contract finalization process as decided by the country legal point of contact . Ensure all the sites are activated as early as possible. Escalate any projected delay to the clinical operations manager and/or CDC Head. Ensuring all the sites are audit and inspection ready. Qualifications You should have a bachelor's degree in Life Science, Pharmacy, Nursing qualification or equivalent. You should have at least 5+ years of experience in clinical monitoring with basic GCP qualification and high level of understanding of GCP requirements. You must have advanced level knowledge of Excel and PowerPoint presentation. Good working knowledge of electronic clinical trial systems – VEEVA, EDC, IWRS, electronic TMF. Good Communication and should be able to collaborate with internal and external stakeholders.
