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Data Management Opportunities at Parexel

Discover Parexel, a premier service provider for the global pharmaceutical industry that can offer you the opportunity to make a profound difference in millions of lives. You'll be immersed in diverse projects that keep you challenged every day, as well as surrounded by colleagues who share your passion and dedication. Bring life-saving treatments to the world with a Data Management job at Parexel. You'll collaborate with a diverse multi-functional team and use an array of technologies on global projects. In addition, our fast-paced environment will give you an opportunity to learn something new every day while you support the accurate collection, organization and analysis of clinical data on small and large studies. Achieve your personal and professional goals with a career in Data Management at Parexel. Our advancement opportunities, individual development and professional growth programs will inspire you to be your best each and every day. If you're a motivated team player, eager to make an impact within Parexel and in the world, join us.

Senior Clinical Data Coder

Job ID 56271BR Bengaluru, Karnataka, India
The role of the Clinical Data Coder (Sr. CDC) is to perform assigned tasks or activities in clinical data coding. Activities may include user acceptance testing (UAT), coding, generation and integration of queries, running of reports. Further responsibilities include support on Coding setup through to database lock on assigned projects and with minimal direction/supervision. Undertakes the Primary CDC role on designated studies. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other international regulatory requirements
• Efficiently manage clinical coding activities on assigned studies
• Create and resolve coding queries
• Review coding UTRs for accuracy and consistency of coding
• Coordinate with team members within the assigned studies
• Communicate timelines and coding requirement across functional teams.
• Responsible for completeness, timely delivery and quality of clinical data
• Assist in coding tool set up for the assigned trials.
• Creation of test data/Test scripts for User Acceptance Testing
• Perform Technical peer review and functional QC activities
• Create clinical study documents which includes Coding conventions, coding definitions, coding configuration specification, coding approval form and UTR template etc.
• Support in archival of Clinical Study Documents as appropriate
• Act as SME for coding application.
• Identify and provide inputs for process improvements.
• Support in development and maintenance of synonym list
• Integration of eDC and coding tool (PACE)
• Study specific EDC Platform – Coding software verification
• Perform coding review and provide feedback on coding quality for coders

Qualifications

Skills:
• Excellent technical skills including but not limited to the knowledge of Clinical Trial/Clinical coding/Data Management/ Coding Systems, MS-Office products
• Comply with coding SOP, manuals and best practices.
• Ability to plan tasks and complete them within the appropriate timescale and to the required quality
• Ability to work in team environment
• Ability to understand and comply with the Protocol
• Good analytical skills and attention to detail
• Excellent interpersonal, verbal and written communication skills
• Effective time management in order to meet team objectives

Knowledge and Experience:
• Must be able to demonstrate proficiency with several tasks included in coding setup-up through data-base lock.
• Solid understanding of clinical trials methodology and current ICH-GCP, FDA guidelines and regulations applicable to conduct of clinical research
• Experience of working on different coding tools.
• Understanding of MedDRA and WHODD coding dictionaries and medical terminologies
Education:
• Bachelor’s degree and/ or other medical qualification or relevant coding or Data Management experience

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