Clinical Data Coder 1
16 hours ago
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 mínimal guidance).
- 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.
- 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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