What is your mission?
The Medical Coder will be responsible
for accurately coding medical terminology and clinical trial data using
standardized coding systems, ensuring high-quality and consistent data output
for regulatory submissions and clinical research reporting. The Medical Coder
will work closely with data management teams, clinical teams, and project
managers to support the accurate classification and coding of medical terms,
adverse events, and concomitant medications.
The role
requires strong attention to detail, collaboration with cross-functional teams,
and a deep understanding of medical codes within clinical trials. The
successful candidate will work closely with the clinical and medical teams to
ensure all safety documentation meets regulatory standards.
Coding
Medical Terminology:
o
Experience using MedDRA and WHODrug to code
adverse events, medical histories, and medications.
o
Assign
standardized medical codes to adverse events, diagnoses, and procedures.
o
Ensure
consistency and accuracy in the application of coding rules across clinical
trials.
Data
Quality Assurance:
o
Conduct
quality control checks on coded data and ensure consistency with source
documentation.
o
Resolve
coding discrepancies and participate in data review meetings to address any
coding-related queries.
Collaboration
and Communication:
o
Work
collaboratively with clinical data managers and clinical research associates
(CRAs) to ensure timely and accurate coding.
o
Communicate
with study teams regarding the status of coding and any issues that may arise.
Maintenance
of Coding Dictionaries:
o
Maintain
and update coding dictionaries to reflect the latest standards and regulatory
guidelines.
o
Implement
updates and changes to coding dictionaries across ongoing studies as needed.
Documentation
and Reporting:
o
Document
coding decisions and maintain a log of coding queries and resolutions.
o
Generate
coding reports and summaries for project teams and regulatory submissions.
Training
and Compliance:
o
Stay
current with the latest developments in medical coding standards and regulatory
guidelines.
o
Provide
training or guidance to study teams on coding practices and regulatory
requirements as necessary
Data
Review and Quality Checks
o
Understand
and comply with study protocols: Effectively utilize available resources; Use
appropriate methods for quality survey conduct and quality assurance measures
for accurate data collection and entry. Accurately track current
timepoints to ensure timely completion of study objectives.
o
Adhere
to protocols for internal audits on data completeness, validity, and accuracy.
o
Perform
data validation checks monitoring for missing data as well as data entry
discrepancies.
o
Perform
validation and user functionality checks on newly created forms prior to those
forms going live in a database.
o
Perform
UAT on new registries and platforms prior to those going live in the database.
o
Input
tester data to enable project validation.
Who are we looking for?
-
Proven experience (8 years) in a senior
client services role within an offshoring, outsourcing, or similar
industry.
-
Demonstrated success in managing complex
client relationships, driving client satisfaction, achieving revenue
growth, and building accounts.
-
Strong understanding of offshoring
operations, processes, and best practices.
-
Exceptional leadership and team management
skills, with a track record of building and developing high-performing
teams.
-
Excellent communication, negotiation, and
interpersonal skills.
-
Strategic thinker with the ability to
identify and capitalize on opportunities for business expansion.
-
Results-oriented mindset with a focus on
achieving performance metrics, sales targets, and client-centric
outcomes.
-
Proficiency in CRM systems and project
management tools.
