Job Description

JOB DESCRIPTION Brief Position Description: The core responsibility for this position is as a member of the Data Management department at Novotech. The Clinical Data Programmer-II (CDP-II) will be responsible for programming activities on clinical trial projects and to ensure compliance with Good Clinical Data Management Practices (GCDMP). Minimum Qualifications & Experience: Graduate in information science or life science related field, or similar. Two years\' experience in a similar role in a CRO or pharmaceutical company. Responsibilities The CDP-II shall be responsible for programming activities on a project. This shall include designing and implementation of clinical database, programming of data review listings and programming of data reconciliation. The CDP-II shall ensure quality standards per SOPs and ICH-GCP. 1. The CDP-II shall be responsible for designing, programming, testing and maintenance of clinical trial databases in different clinical trial applications in accordance with Novotech standards. 2. Perform external data loads, i.e. labs, ECGs etc., as needed. Act as liaison with vendors to establish data transfer specifications standards. 3. Ensure all programming activities and processes performed are conducted in accordance with standard operating procedures and good programming practices. 4. Experience in developing, validating, and maintaining clinical trials built in different EDC applications 5. Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets. . 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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