Principal Clinical Data Programmer at Novotech Global

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

01 Jun, 26

Salary

0.0

Posted On

03 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Database Design, Data Review Listings Programming, Data Reconciliation Programming, Clinical Trial Databases, Testing, Maintenance, Clinical Data Delivery Lead, SOP Compliance, ICH-GCP, Medidata Rave, Viedoc, Data Integration, Object Oriented Programming, C#, Java, Time Management

Industry

Biotechnology Research

Description

About the Role The Principal Clinical Data Programmer shall be responsible for programming activities including design and implementation of the clinical database, programming of data review listings and programming of data reconciliation and ensuring quality standards per SOPs and ICH-GCP. Responsibilities: * The PCDP shall be responsible for designing, programming, testing and maintenance of clinical trial databases as well as programming of data review listings and programming of data reconciliation * Serves as the clinical data delivery lead on multiple study specific programming setup, leading clinical data programming activities on multiple studies of simple to moderately complex design, with competent clinical data delivery experience and knowledge.. * Ensure all programming activities and processes performed are conducted in accordance with standard operating procedures and good programming practices. * Developing, validating and maintaining clinical trials built in different EDC applications - Medidata Rave and Viedoc * Experience with integrating multiple complex clinical study data throughout the entire study lifecycle, from protocol development to database lock. Experience and Qualifications: * Graduate in information science or life science related field, or similar. * Six years experience in a similar role in a CRO or pharmaceutical company with experience in Medidata Rave and Viedoc * Ideally you will have experience in object oriented programming such as C# and Java * Ability to learn new process, programming languages and adapt with new technologies * An ability to work flexibly as part of a team and with a variety of internal and external customers * Demonstrated ability to meet deadlines and manage time and high-volume workflow effectively 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 one 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 talking to you about working at Novotech. Novotech is a global full-service clinical Contract Research Organization (CRO). Headquartered in Sydney, Australia, Novotech has 34 offices across Asia-Pacific, North America, and Europe. Novotech employs over 3000 employees and has over 5000 site partnerships and the resources and infrastructure to scale regionally and globally as clinical programs advance. 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. At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences. At Novotech you will work alongside empowered teams with a shared commitment to success. * Strategic vs transactional mindset. * Ability to gain insights and make proactive decisions quickly. * Culture that fosters partnership and collaboration, where every voice is heard and valued. * Ongoing support from senior stakeholders and leadership team. .

Responsibilities

The Principal Clinical Data Programmer is responsible for all programming activities, including designing, implementing, testing, and maintaining clinical trial databases, alongside programming data review listings and reconciliation processes. This role involves leading clinical data programming activities on multiple studies and ensuring all work adheres strictly to standard operating procedures and ICH-GCP quality standards.