Sr Analyst, Clinical Data Management (Medical Coder) Irvine, CA
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The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.
As a Sr. Analyst, Clinical Data Management (Medical Coder), you will provide medical coding and lead related activities to support clinical trials. This is a newly created position for Edwards Lifesciences, one of the world’s most influential and innovative companies developing medical technologies for structural heart diseases.
Key Responsibilities:
Lead all medical coding activities and the start-up coding configuration in collaboration with other functions (e.g., Safety, Project Management, Clinical Programming) for all assigned clinical study projects to ensure successful deliverables with completeness and accuracy, within established timelines, and in compliance with all processes, guidelines, and conventions.
Perform periodic review of coded data for assigned study clinical projects using industrial coding dictionaries (e.g., MedDRA, WHO Drug), in collaboration with other functions, to ensure the consistency, accuracy, and compliance of the coded terms.
Provide periodic medical coding deliverables, metrics, and issues to leadership and/or study project teams on assigned clinical study projects, as needed
Participate in the full spectrum of the maintenance and upgrade of the medical coding dictionary versions, including, but not limited to, managing coding dictionary versions, completing up-versioning of coded-term tasks, verification of updated dictionary versions, testing, and documentation.
Conduct testing responsibilities regarding coding dictionaries, study database, and/or clinical medical coding system for any new or revised study database build or updates.
Participate in cross-functional process improvement initiatives to review and enhance the workflow for medical coding tasks, coding data integration, review, monitoring, and reporting, following clinical research regulations and industrial standards.
Perform quality oversight of external vendors who provide coding services, to ensure completeness and accuracy, within established timelines in accordance with clinical study protocol, coding processes/ guidelines, and regulations.
Lead cross-functional development and review of SOPs, work instructions, and associated documents in medical coding area, including recommending revisions and updates to SOPs, maintaining best practice, and participating in the development of user training.
Provide training on coding processes and practices to other junior coding members, and/or other functional members.
Other incidental duties assigned by Leadership
Minimum Qualifications
Bachelor's Degree in Life science or health related field, 5 years’ experience of Medical Coding experience in the CRO, pharmaceutical, biotechnology, or medical device industries Required OR Master's Degree or equivalent in Life science or health related field, 3 years of Medical Coding experience in the CRO, pharmaceutical, biotechnology, or medical device industries Required
General Expectations
Experience with hierarchical dictionary reporting structure and versioning of industry’s medical dictionaries (MedDRA and/or WHO-Drug) in a clinical research environment
Experience with medical coding system using industry’s medical dictionaries (MedDRA and/or WHO-Drug) in relation with Data Management’s Electronic Data Capture (EDC) system, especially Coder in Medidata Rave EDC system
Knowledge of medical terminology
Certified Medical Coder a plus
Familiarity of ICH, CFR and other regulatory requirements in the clinical research environment, especially, pertaining to clinical data management and/or medical safety
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills
Excellent problem-solving and critical thinking skills. Develops solutions to a variety of complex problems.
Work is performed independently on complex projects and/or lines of work and reviewed for accuracy and soundness
Full knowledge and understanding of policies, procedures and guidelines relevant to clinical research
Familiarity of processes and procedures in clinical data management
Working knowledge of protocols, DMPs, and SAPs
Proven expertise in Microsoft Office Suite
Ability to manage competing priorities in a fast-paced environment
Strict attention to detail
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Travel (day and overnight by car, air, train, etc.) will vary. Percentage of time is determined by Management