Clinical data coder 1 (MedDRA, WHODD)

Project role :

Work experience :

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Must Have Skills:

Job Overview:

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

• Serve independently as a Clinical Data Coder and/or Lead Coder or DOC for one or more protocols.
• Manage delivery of coding activities and/or stand alone coding projects through full study life-cycle (with minimal guidance).
• Validates/tests the coding application and programming of coding reports • may also test coding related datasets, coding related edits or any coding related programming activities.
• Perform comprehensive data management and coding related tasks including, conducting data review and writing and resolving data clarifications.
• Manage coding related project timelines with guidance from the DOC or Data Team Lead (DTL) or Manager.
• Perform Serious Adverse Event (SAE) reconciliation activities.
• May serve as a back-up for a Lead Coder, DOC or DTL.
• Perform comprehensive quality control procedures, Assist in implementing new technology. • Independently bring coding and project related solutions to the DM team.
• Handle audit requirements for respective studies including stand-alone 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 objectives as assigned
• Develop and maintain good communication and working relationship with the team.

Educational Qualification:

• Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent
• Excellent knowledge of medical terminologies, pharmacology, anatomy and physiology.
• In-depth knowledge of medical dictionaries used for coding (e.g., MedDRA, WHODD etc.).
• Understanding of the Data Management process from study start-up through to database lock.