Clinical Data Associate Ii

**Organization Description**

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 2,000 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

**Employer Description**

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.

**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.

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.

**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 project.

8. May coordinate activities related to coding and electronic data transfers, and address resulting discrepancies.

9.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.

10.Participation in project meetings as requested by CDM.

11.Assist with agenda/minute writing for data management teams.

12.Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities.

13.Provide general admin support to Data Management according to the needs of the Clinical Data Manager.

14.Active contribution to company process improvement initiatives as assigned.

15.Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.

16.Participation in industry fora (conferences, professional associations, etc) as a means of professional development as well as promotion of Novotech' s image in industry.

17.Any other tasks associated with the day-to-day functioning of the DM Team as per the discretion and delegation of the Line Manager.