Require Senior Clinical Data Coder at IQVIA | B.Pharm, B.Sc
Quintiles and IMS Health have come together to become IQVIA, The Human Data Science Company. Inspired by the industry we help, IQVIA commits to providing solutions that enable life sciences companies to innovate with confidence, maximize their opportunities and ultimately drive human health outcomes forward.
Post : Senior Clinical Data Coder
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.
• May perform review of coded data ensuring quality and consistency of coding deliverable.
• 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.
• Independently bring coding and project related solutions to the DM team.
• Handle audit requirements for stand-alone coding projects.
• Assist in implementing new technology.
• Understand and comply with core operating procedures and work instructions.
• Meet objectives as assigned.
• Develop and maintain good communications and working relationships with the DM team.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Excellent knowledge of Medical Terminology, Pharmacology, Anatomy, or Physiology required for many tasks.
• Thorough 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.
• Knowledge of operating procedures and work instructions and the ability to apply them in practice.
• Solid understanding of Drug Development Process and its relevance to Data Management.
• Comprehensive understanding of database technologies related to data management and coding.
• Excellent organizational, communication and leadership skills.
• Excellent English written and oral communication skills.
• Ability to work on computer systems with ease and good working knowledge of computer programs.
• Ability to exercise excellent attention to detail and act independently with the initiative required to resolve problems.
• Ability to establish and maintain effective working relationships with co-workers, managers and sponsors
• Able to make independent decisions within scope of authority and considers the impact of decisions on other groups/people.
• Effective team management skills including conflict resolution, delegation, and change management.
• Excellent interpersonal skills.
• Bachelor’s degree, or educational equivalence in pharmacy, life sciences or related field or medical, nursing qualification with 2 years relevant experience or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS (any specific physical attributes or limiting factors to be accounted for):
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive need to view computer screen for extended periods of time
Qualification : Bachelor’s degree in pharmacy, life sciences
Location : Karnataka-Bangalore
Industry Type : Pharma
Functional Area : Clinical Data Management
End Date : 20th December, 2018
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