Job Description

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Brief Position Description:

The Clinical Data Programmer III (CDP-III) is responsible for clinical database, edit checks and application development work in Electronic Data Capture (EDC) systems and related software applications used for capturing clinical data across multiple clinical projects, ensuring that the CDP deliverables are developed in accordance with SOPs, programming best practices, and in line with the timelines agreed with the Project Team. The CDP-III works under the supervision of the Team Lead CDP to address and resolve issues at technical and clinical database development level and assists in assessing the scope and impact of changes to an existing clinical study database and related applications.

Minimum Qualifications & Experience:

• Graduate in information science or life science related field, or similar.
• More than three years\' experience in a Clinical Data Programmer role in a pharmaceutical company, CRO or EDC software provider, including supervision and training of other programmers.
• Familiar with programming languages including Java and C#.
• Expert knowledge of SDLC methodology.

Responsibilities:

• Participate in Client and Project meetings as required in consultation with the Team Lead CDP to explain the CDP requirements, process and through-put Times.

Advise other Biometrics functions, Project Management and clients in consultation with the Team Lead CDP with respect to the application of CRF libraries and data dictionaries based on CDASH and SDTM.

• Advise Clinical Data Managers, Project Managers and other Biometrics functions in consultation with the Team Lead CDP on the configuration of non-EDC applications that need to interface with the EDC system and their impact on study timelines and costs.
• Undertake database configuration, programming of study database edit checks, custom functions, and clinical and operational progress reports.

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 Us: Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. 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.

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.

Novotech