Supports the day-to-day operations of the data management projects, providing in-house data entry support to projects and administrative support to CDMs, according to GCDMP guidelines, local regulatory requirements and Novotech/Client SOPs.
Responsibilities:Member of the project team reporting to the Biometrics Project Manager on projects, the Clinical Data Associate I is responsible for providing accurate data acquisition, data validation and reconciliation to the clinical studies and shall ensure quality standards per SOPs and ICH-GCP.
- Data entry of clinical trial data using Clinical Data Management software.
- Assistance in review of data queries to be raised with sponsor companies/monitoring staff.
- Tracking of CRF pages received and entered, tracking of data queries sent received and entered.
- Assist CDM with database testing and edit checks testing as appropriate.
- Assist CDM with data cleaning/validation and reconciliation of external data
- Develop and maintain good communications and working relationships with lead CDMs.
- Assist CDM to create reports, listings, and other output as required during the course of the project.
- May coordinate activities related to coding and electronic data transfers, and address resulting discrepancies.
- Assist with the development and update of systems to track study progress as per the CDM requirements (i.e. Novotrak, CRF & query flow, safety reports, etc.). Provide updates on study progress to CDM as required.
- Participation in project meetings as requested by CDM.
- Assist with agenda/minute writing for data management teams.
Minimum Qualifications & Experience:
- Graduate in a clinical or life sciences related field.
- Relevant experience/qualifications in allied professions may also be considered.
- Preferably at least six months to one year experience working in the research, pharmaceutical industry or a related field.
Novotech is a global full-service clinical Contract Research Organization (CRO).
At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
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.
Skills Required
- Graduate degree or qualification in a clinical or life sciences-related field
- Relevant experience or qualifications in an allied profession
- Six months to one year of experience in research, the pharmaceutical industry, or a related field
What We Do
Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, "Novotech" and "PPC". Novotech is a full-service clinical CRO with labs, phase I facilities, and drug development consulting services.
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