Clinical Project Specialist

Clinical Project Specialist #clinicalresearch #clinicaltrials #clinicaldataanalyst #REGULATORYaffairs #medicalcoding #medicalbilling #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #clinicareers #pharmacovigilance #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #phd #oncology #drugdevelopment #cra #biotechnology # About Novotech: Novotech is internationally recognized as the leading independent and fullservice contract research organization CRO in the Asia Pacific region. We provide a wide range of clinical development services across all research phases and therapeutic areas; and have been instrumental in the success of hundreds of Phase I IV clinical trials throughout the Asia Pacific. Powered by the highest quality people, Novotech strives to set the benchmark for both business and clinical trial performance. Our people are one of our key strengths. We value our people and recognise the work they do. We are lucky to have the best people and talent from across the Asia Pacific region work together to deliver to clinical trial success for our clients. Our people and those we look to recruit have an attitude of making things happen. They are problem solvers, driven with a focus on delivering quality, accountability and a high level of performance. About the position: The Clinical Project Specialist CPS supports the day to day operations of the clinical projects, providing inhouse administrative support to the project team, according to project requirements, ICH GCP guidelines, localglobal regulatory requirements and NovotechClient SOPs. The CPS will also contribute to the Clinical Operations Support function in review and maintenance of systems, processes, tools and standards. Core responsibilities: Identify and recommend a selection of key indications and therapeutic areas in AsiaPacific based on the epidemiology of the disease, level of clinical activity and patient recruitment barriers as well as other orphan indications. For selected indications, map key opinion leaders and centers of excellence for based on scientific elements such as publications and historical connections with biotechnology companies. Required Qualifications: Degree in Life Science or related field Pharmacy, Medical, Biology Required Professional Experience: Practical experience andor qualifications in business administration or healthcare administration. At least 3 years experience in a Clinical Trial Assistant CTA role, including Senior Clinical Trial Assistant SCTA or equivalent. CRO andor Pharmaceutical experience is essential. Other Required skills: Perform responsibilities of SCTA refer to job description; to the highest competency levels and extensive a delegation from Project Manager PM and senior team members. Take on Lead Clinical Trial Assistant LCTA responsibilities on regional studies providing additional toplevel support to PMLead Clinical Research Associate LCRA while coordinating the regional CTA team. Liaise directly with clientalliance partner counterpart with respect to assigned responsibilities. Provide Study Program assistance ensuring consistency in administrative processes, tracking, reporting and communication across study teams. Assist PM and Project Director PD with CTMS metrics reports analysis, producing reports, gap and trend analysis, highlighting red flags and following up for completion. Contribute to the maintenance and delivery of CTACRA Essentials Training Programmes and serve as trainermentor to CTAs & SCTAs. May undertake line management responsibilities of the CTA team as required to assist the Clinical Operations Management team. In collaboration with Clinical Operations Management team, assist with review and maintenance of Clinical Operations Support processes, tools and SOPs as requested. Participate in clinical IT key systemsapplications implementation and upgrades as required. Provide specialist support and training to selected teams with respect to set up and implementation of a processor system e.g. Project Financial Support, CTMS or document management AdminSuper User, safety management, regulatory support. Understand company processes in areas relevant to a CPS. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out the CPS role. Participate in activities of the Clinical Operations department, including a presentation at a clinical team meetings e.g. CTA forums, attendance at company meetings and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. Opportunities and benefits: To deliver clinical trial and research excellence for our clients, our people are 'best in class'. At Novotech, we seek and nurture people with exceptional talent. We are committed to providing our people with regular internal and external training, a competitive bonus structure and a supportive work environment. We are also focused on providing our people with a wide variety of career growth and development opportunities. For more information about where your next career step at Novotech might take you, visit http:novotechcro.comnovotechcareers