Clinical Coding Specialist
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 lead a project as Data Operations Coordinator (DOC) or Data Team Lead (DTL)).
Serve independently as a Clinical Data Coder, Lead Coder and/or Coding reviewer for one or more projects.
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.
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.
Perform comprehensive quality control procedures.
Perform Serious Adverse Event (SAE) reconciliation activities.
Independently bring coding and project related solutions to the DM team.
Handle audit requirements for stand-alone coding projects.
Solves coding related issues through using the global issue escalation/communication plan.
Responsible for continuous process improvement and implement process improvement initiatives by working with relevant process experts.
Assist in developing and implementing new technology.
Understand and comply with core operating procedures and work instructions.
Perform other duties as directed by the DOC, DTL or Manager.
Meet objectives as assigned.
Develop and maintain good communications and working relationships with CDM team.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
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.
Comprehensive 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 and managers.
Understand 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.
Effective team management skills including conflict resolution, delegation and change management.
Excellent interpersonal skills.
Able to establish trust and collaborative relationships with Customers.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree, or educational equivalence in pharmacy, life sciences or related field or medical, nursing qualification
with 3 years relevant experience including clinical trials experience in a function similar to Data Management 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