Clinical Data Coder

Role:

Clinical Data Coder (MedDRA, WHODD)

Location:

Kochi/Kolkata/Bangalore/Thane Experience:

3+ years of relevant experience in clinical data coding Work Mode

: Hybrid

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 • 3 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