• Responsible for execution of Central Report Review activities on the study • May support development of annotated visit reports • Reviews the content and quality of site and central monitoring documentation • Ensure deliverables are provided according to company and/or sponsor specifications • Documents observations noted during reviews and ensures protocol deviations or action items are reported as necessary

• Review audit packs to verify data and their content for compliance with MDD 93/42 EC or MDR (EU) 2017/745 • Take decisions on reviewed audit packs to determine certificate issuance and applicable restrictions • Verify that audit documentation for QMS on-site and technical documentation assessment is in compliance with regulations • Review whether the final review has been carried out satisfactorily • Check audit packs for QMS on-site audit for MDD / MDR / ISO13485 • Involvement in concessions and certificate suspension when relevant • Work with auditors, product assessors, and Global Medical Device Certification Manager to meet operations objectives

• Audit patient medical records using clinical, coding, and payer guidelines to ensure accurate reimbursement. • Provide clear, evidence-based rationale for code recommendations or reconsiderations to providers or payers. • Collaborate with team leaders to ensure thorough review of DRG denials. • Conduct audits in alignment with organizational quality and timeliness standards. • Use proprietary auditing systems proficiently to make consistent determinations and generate audit letters. • Recommend improvements to the audit system to enhance efficiency. • Ensure compliance with HIPAA regulations for protected health information. • Perform other duties as assigned.

• The HSCRC Coding Reviewer will be a subject matter expert in clinical documentation review, clinical data abstraction, clinical coding, auditing, and variables impacting HSCRC payment methodologies that are based in medical record documentation. • Performs compliance audits employing specified protocols and criteria; conducts data abstraction and collection activities; interprets and applies coverage and payment policies, edits, and certification and regulatory requirements for medical necessity and other audit decisions; classifies findings and provides commentary for clinical data, qualitative, and statistical analyses; records rationale for and basis of audit findings using proper grammar and communication methods; writes reports in accordance with company requirements. • Provides feedback to hospitals concerning audit findings and discusses rationales for audit decisions. • Performing audit functions for the HSCRC Inpatient/Outpatient Data Abstract Review Contract in a timely and accurate manner. • Generating well-written deliverables and audit work papers. Outstanding verbal communication skills. Outstanding communications and interactions with hospital and client personnel.