About the Opportunity:
Participates in and executes designated data management functions in accordance with NVT and / or sponsor standard operating procedures (SOPs). CDA I/II will work under supervision and Senior CDA will work independently.
Minimum Qualifications and Experience:
- Bachelor's Degree or equivalent education.
- 1-2 years' clinical data management experience for CDA (I/II); 2-4 years clinical data management experience for CDA (Snr).
Responsibilities:
- Develop screens testing, edit check testing, and completion guidelines for selected project.
- Developing eCRF, annotating CRF, data validation plan for selected project.
- Developing, reviewing and managing the project plans for selected project: data manager plan, data manager report, etc.
- Implement DMP changes to daily work activities, reference data issues log to resolve queries whenever possible, generate data queries; conduct quality control processes including Case Report Forms (CRFs) to database review.
- Perform data cleaning including query activity and Electronic Data Capture (EDC) reconciliation. Identify and report issues and data trends. Communication with regards to issues and concerns along with suggested resolution. Completion of assigned tasks in a timely manner meeting assigned goals for tasks. Run reports as requested and needed for daily tasks.
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Take the responsibilities as follows in BA/BE studies:
- Complete the work for BA/BE project.
- Complete BA/BE project setup, conduct and closeout.
- Make timeline, allocate work content reasonably, guide team members to complete tasks and ensure work quality, finish it on time for BA/BE project.
- Preparation and transfer of information as part of new project team members joining project.
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.
