Clin Data Coder 2

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 (CDM) Coding activities, and provide leadership either in the role of a Lead Coder or Coding Reviewer or as an individual Subject Matter Expert (SME)or lead a project as Data Operations Coordinator (DOC) or Data Team Lead (DTL)).

Essential Functions

• Serve independently as a Clinical Data Coder, Lead Coder and/or Coding reviewer for one or more projects.
• Serve as an account lead, or internal or external point of contact on standalone coding studies or accounts.
• Manage customer relationship for the project team including active participation in coding related customer negotiation on timeline, budgetary and other issues (with guidance).
• Manage resource capacity for the project team.
• Manage delivery of coding activities and/or stand-alone coding projects through full study life-cycle.
• 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.
• Responsible for continuous process improvement and implement process improvement initiatives by working with relevant process experts.
• Collaborate with customers and develop solutions and action plans for issues, escalations and road blocks.
• Develop and implement best practices in the team.
• Manage the development and implementation of new technology.
• Demonstrate scientific and research temperament by presenting at, or participating in local and international forums.
• Develop and maintain good communication and working relationship with team , client and other stakeholders.
• Perform other duties as directed by the study team or Manager, or meet objectives as assigned.
• Provide review and expert opinion in developing, revising, and maintaining core standard operating procedures and work instructions.
• Manage coding related project timelines with guidance from the DOC or DTL or Manager.
• Perform review of coded data ensuring quality and consistency of coding deliverables.
• Manage project timelines and quality issues and determine coding resource needs.
• Identify out of scope work.
• Serve as a back-up for the DOC or DTL or as a DOC or DTL.
• Perform comprehensive quality control procedures.
• Perform Serious Adverse Event (SAE) reconciliation activities.
  
  

• Pharmacy, dental, medical, nursing, life sciences or related field qualification or educational equivalent
• 4 years relevant experience including clinical trials experience in a function similar to Data.
• Management or equivalent combination of education, training and experience.
• Excellent knowledge of Medical Dictionaries used for coding (e.g. MedDRA, WHODD, ICD9, etc.).
• Excellent knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology required for many tasks.
• Good project management skills related to all phases of clinical studies.
• Comprehensive knowledge 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.
• Excellent understanding of the Drug Development Process and Data Management’s relevance to it.
• 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 and managers.
• Understand and interpret financial management concepts.
• Able to present information effectively to individuals and groups.
• Able to make independent decisions within scope of authority and considers the impact of decisions on other groups and people.
• Able to motivate and lead teams to reach defined objectives.
• Effective team management skills including conflict resolution, delegation, and change management.
• Excellent interpersonal skills.
• Able to establish trust and collaborative relationships with customers.