Homeoffice Associate Clinical Data Coder en PAREXEL

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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 supervision of senior coding staff. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other international regulatory requirements.

•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 the verbatim that are ambiguous and issue queries in line with applicable coding conventions.
• Provide regular work status updates to direct supervisor or primary coder and sponsor
• Provide inputs for process improvement

• Assist in coding tool set up for the assigned trials.
• Assist in execution of User Acceptance Testing.

• Report any discrepancies observed with clinical dictionary used
• Report any issues with DBL process and related documentation.

• Ensure that all the scheduled timelines are met for the assigned studies
• Any issues related to coding should be proactively brought to the attention of Line Managers, Reviewers and study teams.
• Comply with Applicable SOPs, manuals trainings and best practices.
• Compliance to 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/potential prior experience in Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs), 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