Job Description

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).Essential Functions

• 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.

Qualifications

• Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent
• 2 years of relevant experience or 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 etc.).
• Understanding of the Data Management process from study start-up through to database lock.
• Ability to exercise excellent attention to detail and act independently with the initiative required 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 language, organizational and leadership skills.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• LPN - Licensed Practical Nurse - State Licensure Req

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