• Primary point of contact for Quality Assurance and Regulatory Agencies. • Manage and support activities during audit/inspections. • Perform, facilitate and manage root-cause-analysis, Corrective and Preventive Actions (CAPAs) as well as responses to audit/inspection findings / reports. • On a regular basis look into local trends, facilitate root-cause-analysis (if necessary) and coordinate the development of local action plans. • Local expert for ICH-GCP, local regulations and any quality-related process. • Manage the local SOP/SME network to ensure a proper implementation of global/regional/local procedures and the regular update of local SOPs. • Identify process improvement opportunities and properly escalate to the CQM Lead and/or Process Owner (if necessary). • Lead or Co-Lead global/regional/local key initiatives/projects/process improvement activities upon request. • Local training point of contact and the liaison between local Learning & Development. • In close cooperation with country operations management, identify local training needs and coordinate related activities. • Deliver quality topics (as needed). • Coordinate and oversee proper execution of all QC activities at country/cluster i.e. In-house Quality Control Plan (IHQCP), Quality Control Visits (QCVs), etc. • Perform QC activities and site visits (when required). • Communicate/escalate quality/compliance issues (incl. any potential trends) to local country operations management or CQM Lead as required. • Support the reporting of ‘Serious Breaches’ where applicable. • Evaluate trends and coordinate GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies. • Lead/support as applicable Local Supplier qualifications and supports solving of quality issues with locally selected Suppliers. • Upon request, support the Quality Management System (QMS) assessment of global Suppliers or conduct/support regional supplier qualifications. • Coordinate or supervise the local vendor privacy assessments (SPA, IRA, ITRMS).

• Oversee and manage all operational aspects relating to Cerapedics clinical studies and clinical evidence generation in the USA • Contribute to the development of clinical evidence strategies to maximize opportunities for data generation • Manage all clinical study project elements from initiation to close-out with an emphasis on study start-up ensuring training and education of investigators and research staff • Monitor study progress and collaborate with CRO and third-party vendors to ensure timely execution of projects and adherence to protocol, budgets and compliance requirements • Support data dissemination activities and communication of clinical study outcomes to internal stakeholders

Role Description The Senior Clinical Quality Operations Coordinator provides advanced oversight and coordination of clinical quality review processes across WelbeHealth. This role is accountable for leading and performing high-level clinical chart audits, universe validations, RAI (Requests for Additional Information) and HPMS (Health Performance Management System) submissions, and other compliance-driven activities to ensure accuracy, timeliness, and data integrity. The Senior Clinical Quality Coordinator serves as a resource for clinical quality standards, supports process optimization initiatives, and partners with Quality Operations leadership and clinical teams to uphold exceptional standards of care and documentation compliance. This role is different because the Senior Clinical Quality Operations Coordinator at WelbeHealth: - Operates at the intersection of clinical care and regulatory compliance, directly influencing audit readiness, CMS reporting (RAI/HPMS), and the integrity of clinical documentation that impacts participant outcomes. - Serves as a clinical quality leader and mentor, driving process improvements while partnering with interdisciplinary teams to elevate documentation standards and audit performance across the organization. On the day-to-day, you will: - Lead and perform clinical chart reviews to validate documentation, coding accuracy, and alignment with regulatory and organizational standards. - Conduct clinical audits, ensuring consistent application of standard operations procedures (SOPs), associated policies, audit protocols, tracking metrics, and identifying trends for process improvement. - Manage and oversee RAIs, as well as verify data completeness, timeline adherence, and accuracy. - Assist in the development of compliance tracking tools, scorecards, dashboards, Root Cause Analyses (RCA), and Corrective Action Plans (CAPs) as needed following audits. - Serve as a subject matter resource for clinical data validation. - Collaborate closely with interdisciplinary and regional/onsite clinical teams to resolve documentation discrepancies. - Assist with supporting coordinators on data review protocols and documentation standards, as well as oversee the work of other clinical coordinators to ensure understanding and develop investigation techniques. Qualifications - Licensed clinical professional (e.g., RN, LVN, or equivalent) with four (4) years of experience in clinical documentation and audit processes. - Minimum of one (1) year of experience in a Quality Operations Coordinator role or equivalent experience required. - Proven competency in clinical data systems, such as Smartsheets and HPMS platforms. - Strong analytical and problem-solving skills to interpret and communicate complex clinical data accurately and to identify trends or discrepancies preferred. - Detail-oriented with advanced proficiency in electronic medical record (EMR) navigation and quality reporting tools. - At least two (2) years of experience in a clinical quality review, utilization management, or related healthcare role. Benefits - Medical insurance coverage (Medical, Dental, Vision). - Work/life balance - 17 days of personal time off (PTO), 12 holidays observed annually, and 6 sick days. - 401K savings + match. - Comprehensive compensation package including base pay and bonus. - And additional benefits! Compensation Offering $99,309.58 — $131,088.64 USD Our Commitment to Diversity, Equity and Inclusion At WelbeHealth, we embrace and cherish the diversity of our team members, and we're committed to building a culture of inclusion and belonging. We're proud to be an equal opportunity employer. People seeking employment at WelbeHealth are considered without regard to race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, marital or veteran status, age, national origin, ancestry, citizenship, physical or mental disability, medical condition, genetic information or characteristics (or those of a family member), pregnancy or other status protected by applicable law. Beware of Scams Please ensure your application is being submitted through a WelbeHealth sponsored site only. Our emails will come from @welbehealth.com email addresses. You will never be asked to purchase your own employment equipment. You can report suspected scam activity to fraud.report@welbehealth.com.

• Lead operational contact for clinical studies • Provide strategic and operational leadership to the clinical operations team • Ensure project milestones delivery on time, within budget, high quality, and in compliance • Responsible for all operational aspects, strategic input, and progress of clinical trial • Manage vendor activities to support clinical studies • Oversee study timelines and budget planning • Participate in country and site feasibility/selection process • Ensure studies are 'inspection ready' at all times • Create and foster strong strategic partnerships with colleagues