Require Clinical Data Associate at Novotech

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.

Post : Clinical Data Associate II

Brief Position Description
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 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.
1. Data entry of clinical trial data using Clinical Data Management software.
2. Assistance in review of data queries to be raised with sponsor companies/monitoring staff.
3. Tracking of CRF pages received and entered, tracking of data queries sent received and entered.
4. Assist CDM with database testing and edit checks testing as appropriate.
5. Assist CDM with data cleaning/validation and reconciliation of external data
6. Develop and maintain good communications and working relationships with lead CDMs.
7. Assist CDM to create reports, listings, and other output as required during the course

Minimum Qualifications & Experience :
Graduate in a clinical or life sciences related field. Relevant experience /qualifications in allied professions may also be considered.
At least one to two years' experience working in the research, pharmaceutical industry or a related field.
Additional Information
Qualification : Graduate in a clinical or life sciences
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Job Identification : 2766
End Date : 31-10-2024