Essential Functions:
- Serve independently as a Clinical Data Coder and/or Lead Coder or DOC for one or more protocols.
- Manage the delivery of coding activities and/or stand-alone coding projects through the full study life cycle (with minimal guidance).
- Validate/test the coding application and programming of coding reports.
- 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.
- Serve as a backup for a Lead Coder, DOC, or DTL.
- Perform comprehensive quality control procedures and 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 relationships 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 required.
