Clinical Data Associate II

Novotech

India
Permanent
Full-time

1 month ago

Job Description:Minimum Qualifications & Experience:Graduate in a clinical or life sciences related field. Relevant experience /qualifications in allied professions may also be considered. At least two to four years data management experience working in research, pharmaceutical industry, or a related field.ResponsibilitiesMember of the project team reporting to the Biometrics Project Manager on projects, the Clinical Data Associate II 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 and assist 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 and assist CDM with data cleaning/validation and reconciliation of external data.
Assist CDM to create reports, listings, and other output as required during 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.) and provide updates on study progress to CDM as required. Also, assist with agenda/minute writing for data management teams.

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.

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