Clinical Data Associate

Avance Clinical Pty Ltd.; Bengaluru South; On-site; INR 400,000 - 700,000; Full time

Job summary

Avance Clinical Pty Ltd. is seeking a Clinical Data Associate (CDA) in Bengaluru, India. The role focuses on developing study-related documents, data management plans, and data cleaning under mentoring.

You’ll engage with cross‑functional teams to ensure quality and regulatory compliance. The successful candidate will have a life sciences degree, at least two years as a CDA in CRO/Pharma, and solid knowledge of ICH GCP and privacy rules.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, nursing or equivalent field (highly regarded), or appropriate industry experience.
• At least 2 years’ experience as a CDA in a CRO or Pharma company.
• Working knowledge of ICH GCP and applicable regulatory requirements.
• Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
• An understanding of Privacy Legislation as it applies to the Clinical Trial Environment.

Responsibilities

• Develop study-related documents or plans under the supervision of the Data Team Manager.
• Preparation of Data Management Plans and assist with development of Edit Check Document with the support of a mentor.
• Preparation of clean and erroneous dummy data.
• Perform data review and cleaning of data collected during the trial and raise queries in the database while conducting cleaning activities for eCRF studies.
• MedDRA / WHO-DD Coding with the support of a mentor and/or review of coding.
• Liaise with a variety of different team members to ensure good communication across each study.
• Archiving of studies, including EDC specific documentation.
• Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
• Provide guidance and mentoring to less experienced CDA team members.

Skills

CDA experience

ICH GCP knowledge

Regulatory understanding

Communication skills

Education

Bachelor's degree in life sciences

Job description

Who are we?

We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.

Who are we?

We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.

Why should you join Avance Clinical?

We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success. We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal.

Broad Purpose

• Develop study-related documents or plans under the supervision of the Data Team Manager
• Preparation of Data Management Plans and assist with development of Edit Check Document with the support of a mentor.
• Preparation of clean and erroneous dummy data.
• Perform data review and cleaning of data collected during the trial and raise queries in the database while conducting cleaning activities for eCRF studies.
• MedDRA / WHO-DD Coding with the support of a mentor and/or review of coding.
• Liaise with a variety of different team members to ensure good communication across each study.
• Archiving of studies, including EDC specific documentation.
• Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
• Provide guidance and mentoring to less experienced CDA team members.

Qualifications, Skills And Experience

• Bachelor’s level degree in life sciences, pharmacy, nursing or equivalent field (highly regarded), or appropriate industry experience.
• Previous experience as a CDA in a Contract Research Organisation (CRO) or Pharma company for at least 2 years.
• Working knowledge of ICH GCP and applicable regulatory requirements.
• Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
• An understanding of Privacy Legislation as it applies to the Clinical Trial Environment.