Clinical Data Coder, cFSP

Job Overview

Provide comprehensive data management expertise to the Data Management (DM) team, ensuring efficient and high-quality data management products that meet sponsor and company needs. Perform Clinical Data Management and/or Coding activities, and may provide leadership as a Lead Coder or in a specific CDM task (e.g., Data Operations Coordinator (DOC) or leading a coding-related task on a large trial).

Essential Functions

• Serve independently as a Clinical Data Coder, Lead Coder, or DOC for one or more protocols.

• Manage the delivery of coding activities and/or standalone coding projects throughout the full study lifecycle with minimal guidance.

• Validate and test coding applications and programming of coding reports.

• Test coding-related datasets, edits, or any programming activities related to coding.

• Perform comprehensive data management and coding tasks, including data review and writing and resolving data clarifications.

• Manage coding-related project timelines with guidance from the DOC, Data Team Lead (DTL), or Manager.

• Perform Serious Adverse Event (SAE) reconciliation activities.

• Serve as a backup for a Lead Coder, DOC, or DTL as needed.

• Perform comprehensive quality control procedures and assist in implementing new technology.

• Independently provide coding and project-related solutions to the DM team.

• Handle audit requirements for respective studies, including standalone coding projects as applicable.

• Understand and comply with core operating procedures and work instructions.

• Perform other duties as directed by the study team or Manager, or meet assigned objectives.

• Develop and maintain effective communication and working relationships with the team.

Qualifications

• Qualification or educational equivalent in Pharmacy, Dental, Medical, Nursing, Life Sciences, or a related field.

• 2 years of relevant experience or an equivalent combination of education, training, and experience.

• Excellent knowledge of medical terminologies, pharmacology, anatomy, and physiology.

• In-depth knowledge of medical dictionaries used for coding (e.g., MedDRA, WHODD).

• Understanding of the Data Management process from study start-up to database lock.

• Strong attention to detail and the ability to act independently with initiative to resolve problems.

• Good understanding of database technologies related to data management and coding.

• Knowledge of operating procedures and work instructions and the ability to apply them in practice.

• Excellent written and oral communication skills in English, along with strong organizational and leadership skills.

• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com