Remote CDM Jobs at Parexel – Apply Online
Associate Clinical Data Coder
India-Bengaluru-Remote
Time Type: Full-time
Posted On: Posted Yesterday
Job Requisition ID: R0000031064
When our values align, there’s no limit to what we can achieve.
At Parexel, we all share the same goal – to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy, and we’re committed to making a difference.
Associate Clinical Data Coder
The role of the Associate Clinical Data Coder (ACDC) is to perform assigned tasks or activities in clinical data coding. Activities may include coding of clinical data, generation, integration of queries, and running of reports under the supervision of senior coding staff. All tasks should be performed in accordance with corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP, and/or other international regulatory requirements.
Responsibilities:
- Perform the clinical coding mapping using coding dictionaries and map to the nearest Low Level Term (LLT) or Drug Name as the case may be.
- Identify verbatim terms that are ambiguous and issue queries in line with applicable coding conventions.
- Provide regular work status updates to the direct supervisor or primary coder and sponsor.
- Provide inputs for process improvement.
- Assist in coding tool setup for the assigned trials.
- Assist in the execution of User Acceptance Testing.
- Report any discrepancies observed with the clinical dictionary used.
- Report any issues with the DBL process and related documentation.
- Ensure that all scheduled timelines are met for the assigned studies.
- Proactively bring any coding-related issues to the attention of Line Managers, Reviewers, and study teams.
- Comply with applicable SOPs, manuals, training, and best practices.
- Ensure compliance with regulatory requirements (e.g., ICH-GCP).
Skills:
- Ability to work and collaborate in a team environment.
- Learning ability and knowledge-sharing approach; swift understanding of technologies and new processes.
- Demonstrates attention to detail and commitment to First-Time Quality, including a methodical and accurate approach to work activities.
- Good interpersonal, oral, and written communication skills.
- Written and oral fluency in English.
Knowledge and Experience:
- Basic knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODrug).
- Awareness or potential prior experience in Clinical Trial/Data Management Systems (e.g., InForm, Rave, Veeva, DataLabs), and Microsoft Office products.
- Basic awareness of Data Management processes and data flows.
- Awareness of regulatory requirements (e.g., ICH-GCP).
Education: Bachelor’s degree and/or other medical qualification or relevant coding or Data Management experience.
Editor’s Note: Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo
