Job Description

JOB DESCRIPTION Brief Position Description: The Clinical Document Specialist (CDS) will provide support for Trial Master File (TMF) activities to the clinical teams for assigned projects. This role will be responsible for the overall management and quality maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the Trial Master File (TMF). The CDS will have a strong focus on ensuring routine document management operations are performed with adherence to Novotech SOPs. This role to manage Trial Master Files (TMF), both electronic and paper in format according to project requirements, ICH GCP guidelines, local/global regulatory requirements, and Novotech/Client SOPs. Minimum Qualifications & Experience: . Minimum bachelor\'s degree with concentration in Life Sciences. . At least 5 years of experience in a clinical research organization or equivalent role. . Practical experience in handling Trial Master File activities including paper or electronic-TMF (eTMF). . Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. . Have good knowledge of eTMF systems Responsibilities: . CDS will perform the responsibilities of the SDMA (refer to job description) to the highest competency and act as both a document uploader and QC reviewer. CDS is responsible to liaise directly with the client/alliance partner counterpart (if assigned) with respect to assigned responsibilities. . CDS will contribute to maintenance and delivery of team Training Programs and serve as a trainer/mentor to new team members. Identify, develop, and lead potential TMF process improvements which can improve centralized workflows and drive efficiencies across Novotech. . May undertake line management responsibilities of the DMA team as required to assist the Clinical Operations Management team. . CDS maintains an understanding of applicable regulatory requirements and changes with TMF Management requirements and keeps Novotech tools and processes updated accordingly. . CDS may lead the development of the assigned project Filing Plan with Team Lead/Project Manager and is involved in assessing overall customer satisfaction for all studies with the central filing function, working with internal and external customers to resolve issues and ensure all SOP requirements are delivered. . Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance. In collaboration with Clinical Operations Management team, assist with review and maintenance of Clinical Operations TMF processes, tools and SOPs as requested. 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. ABOUT THE TEAM 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 to serve biopharmaceutical clients conducting clinical trials in Asia and globally. As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

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