ConcertAI is the leading provider of precision oncology solutions for biopharma and healthcare, leveraging the largest collection of research-grade Real-world Data and the only broadly deployed oncology-specific AI solutions. Our mission is to improve translational sciences; accelerate therapeutic clinical development; and provide new capabilities for post-approval studies to accelerate needed new medical innovations to patients and to improve patient outcomes.
ConcertAI has emerged as one of the highest growth technology companies in Real-world Data and AI, backed by industry leading private equity companies: SymphonyAI, Declaration Partners, Maverick Ventures, and Alliance|Bernstein.
About the Role
Clinical Data Coding Leader (CDCL), you will be responsible for supporting the Director/Sr. Director of Clinical Data Operations with all required activities to achieve business goals for Digital Clinical Trial Solutions .
Key Tasks & Responsibilities
This role will provide YOU the opportunity to build and influence next generation digital trial platform which will drive the integration of healthcare data with the complex clinical trials systems needs by leveraging industry standards, advance integration and AI capabilities.
The Clinical Data Coding Leader (India) is primarily responsible to assist in clinical interpretation and mapping of medical terminologies, semantics and ontology management for setting up and executing studies within an EHR/EMR-EDC integrated Digital Trial Platform and who will be able to provide the end-to-coding specifications, map the CRF documents from clinical perspective to a respective EHR, EMR Documents. A key component is to liaise with functional data management expert and technical data engineering teams for development of EMR to electronic Data capture (eDC) system and workflows and associated coding tools, specifications and hand-on coding of terms and interpretation of clinical data for clinical trials and/or real-world studies managed internally and externally.
- This role essentially acts as a “Functional Subject Matter Expert” for the development of all EMR to EDC “Medical Data Coding processes” and/or tools required for an innovative industry leading “eSource" solution for clinical trials.
- Identify CRF Data Elements forms and fields amongst the data sources and help in mapping the specification from structured data tables as well as unstructured data sources (medical documents e.g. imaging reports, physical notes, prescriptions, etc.) of EMR and EHR
- Work with Data Managers and Technology Team to provide clinical decision support on various data elements that would be part of eCRF and CRF annotation as per CDASH and SDTM .
- Build Clinical metadata repository/Library to support the automation of raw EHR/EMR data mapping with CRF items
- This role ensures data collection applications are consistent with client and industry standards/ CDISC with respect to regulatory compliance and validation requirements
- Perform medical data coding quality checks from EHR/EMR source to EDC to ensure data integrity is maintained
- Lead discussions on EMR TO EDC eSource solution build and be responsible hands-on for the study set-up activities and the technical development of eCRF for Electronic Data capture (eDC) solutions and associated tools for one or more clinical trials and real-world study(ies) managed internally or for external clients
- Works with the Head, Products, Data Acquisition Group and Technical Operations/Engineering Teams to plan/schedule delivery of study eDC build specifications, medical data mapping, and extractions, transformation, and loading
- Basic understanding of Clinical Data Standards “CDISC, CDASH, HL7, FHIR etc.”
- Provide trainings to other staff, do vendor quality assessments, support audits and inspections
We are looking for professionals with these required skills to achieve our goals:
- Graduate in Life Science/Medicine/Paramedical Sciences
- Industry-standard coding certification (CPC/CPC-H/CCS/CCS-P, CMC) from one of the accepted certifying bodies AAPC or AHIMA, WHO, UMC etc.
- Minimum 7 years or higher job experience or similar in Clinical Research and Hospitals, Healthcare or Health Insurance Industry. Lead Coding experience preferred
- Experienced working for the Pharmaceuticals and Biotechnology companies and projects with a special focus to Oncology TA
- Hands-on experience in handling medical dictionaries used in Clinical Trial Industry as well as Healthcare Industry e.g. WHODD, MedDRA, SNOMED, LOINC, ICD, RxNorm, NCI and client specific custom codes, legacy system codes etc.
- Understanding of general data flow & database architecture concepts
- Experience in Quality and consistency check of coding listings.
- Understanding of coding regulatory requirement and protocol related dependencies preferred.
- Coding and Quality Check (QC) experience in coding tool such as Thesaurus Management System (TMS), RAVE Coder and Inform Central Coding.
- Experience in Coding set up activities and UAT preferred.
- Sound knowledge in Clinical trial process and Data management activities
Learn More About ConcertAI
ConcertAI is transforming how healthcare is delivered and dedicated to improving patient outcomes in oncology by offering innovative solutions on how data and intelligence are used to solve healthcare problems. We are creating something special in our culture by building a collaborative, engaged, patient-focused team approach to our mission. Our high-performance teams are looking to add great talent to the mix, and we are hiring for the right combination of new skills and a diverse mindset. Learn more about www.concertai.com, or follow us on LinkedIn..