Clinical Data Associate Ii

1 week ago

Bengaluru, India Novotech Asia Full time

**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**

  • 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, 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 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.
  • Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities.
  • Provide general admin support to Data Management according to the needs of the Clinical Data Manager.
  • Active contribution to company process improvement initiatives as assigned.
  • 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.
  • Participation in industry fora (conferences, professional associations, etc) as a means of professional development as well as promotion of Novotech' s image in industry.
  • Any other tasks associated with the day-to-day functioning of the DM Team as per the discretion and delegation of the Line Manager.

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