Role Description The Clinical Quality Nurse performs clinical quality audits and reviews of prior authorization, inpatient acute and post-acute, complex case management, transitions of care, disease management, and medical claims review case work to evaluate compliance with department policies and regulatory requirements. This role works closely with Case Management leadership to create and revise operational process documents that are used in evaluating case work on audit. You’ll enjoy the flexibility to work remotely from anywhere within the U.S. as you take on some tough challenges. Primary Responsibilities: - Evaluate medical management case work including Prior Authorization, Inpatient Acute and Post-Acute, Complex Case Management, Transitions of Care, and Clinical Claims to determine/verify whether medical necessity criteria were met using industry guidelines (CMS, Health Plan policies, MCG, InterQual, NCQA). - Verify that time requirements for case work were met according to regulatory and departmental standards (CMS, NCQA). - Verify that service providers were in network, or that a gap in network coverage was present. - Follow relevant regulatory guidelines, policies, and procedures in reviewing clinical case documentation and medical necessity criteria selection (e.g., CMS, MCG, InterQual, NCQA). - Follow relevant regulatory guidelines, policies, and procedures in reviewing complex case management, transitional case management, and disease management, to ensure care planning process meets regulatory and departmental requirements (NCQA). - Verify if outreach for additional information was required and followed regulatory guidelines. - Verify that required communication to members and providers was completed as required by regulatory requirements and department policies. - Run/pull/prioritize relevant data/reports (e.g., case level data, audit trends, audit samples). - Manipulate and leverage multiple databases (e.g., provider panels, medical review databases) to sort, search, and enter information. - Identify incomplete/inconsistent information in case reviews and document missing criteria/documentation/concerns. - Provide guidance to clinical staff to improve/standardize case review. - Identify and report quality of care concerns appropriately. - Report inconsistencies/problems with prior authorization, admissions, case management, transitions of care, and/or medical claims case review to appropriate parties for resolution. - Maintain HIPAA requirements for sharing minimum necessary information. - Create and revise process documents in collaboration with process owners. Position Details: - Schedule: Full time, 40 hours/weekly, Monday through Friday, 8:00AM - 4:30PM (Serving EST). - Department: Clinical Quality & Audit. - Location: Telecommuter. Qualifications - Unrestricted current RN licensure in state of residence. - 1+ years of experience conducting medical necessity reviews utilizing established criteria such as CMS guidelines, MCG, InterQual, or NCQA standards. - 1+ years of experience managing complex cases, including care coordination, resource utilization, and multidisciplinary collaboration to achieve optimal outcomes. - Experience operating within multiple platforms that house case documentation and clinical records. - Proficiency in Microsoft Office using Word, Excel, and PowerPoint. - Proven excellent interpersonal and communication skills (both written and oral). - Proven solid critical thinking and decision-making skills. - Proven ability to work on a multi-disciplinary team. Requirements - Bachelor of Science, Nursing (Preferred). - 3+ years of experience in managed care (Preferred). - *All employees working remotely will be required to adhere to UnitedHealth Group’s Telecommuter Policy. Benefits - Comprehensive benefits package. - Incentive and recognition programs. - Equity stock purchase. - 401k contribution (all benefits are subject to eligibility requirements). - Salary range: $60,200 - $107,400 annually based on full-time employment. Application Deadline This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.

• Act as a central liaison among the university, Site Based Learning team, clinical sites, faculty, and students. • Ensure the successful planning, implementation, and evaluation of nursing practicums. • Develop, manage, and maintain clinical affiliation relationships and partnerships across multiple regions. • Oversee scheduling and placement logistics for licensure track programs in the SoNHS. • Monitor site readiness and student satisfaction through feedback loops and evaluation tools. • Serve as a liaison between the university and clinical partners, resolving issues related to placement, student performance, or site logistics.

Title: Associate Director, Trial Lead Clinical Operations (Contract to Perm) Location: Danbury, CT Job Description: MannKind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient‑centric solutions, developing and commercializing innovative inhaled therapeutics and drug‑device technologies aimed at addressing serious unmet needs across endocrine, cardiorenal, and orphan lung diseases. The company applies deep expertise in formulation science and inhalation‑device engineering to reduce the treatment burden for conditions such as diabetes, congestive heart failure, pulmonary fibrosis, and pulmonary hypertension. MannKind’s core technologies, including ultrafine dry‑powder formulations and advanced inhalation platforms, enable rapid, convenient delivery of medicines directly to the deep lung. This approach supports both local pulmonary targeting and systemic delivery for various medical indications. Through alternative drug formulations and delivery mechanisms, MannKind aims to bring forward differentiated, patient‑centric therapies that expand treatment options to improve outcomes across chronic and rare diseases. At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives. Position Summary: MannKind Corporation is currently seeking an experienced global trial lead, Clinical Operations to lead/support the design, planning, implementation and execution of clinical study protocols, operational plans and study timelines for MannKind trials. The role will manage all aspects of study progress, including protocol design, development and planning, study initiation, execution and close-out, and support for the development of clinical study reports, abstracts for professional meetings and publications. The role will ensure adherence to all appropriate regulatory guidelines as well as support the development and implementation of clinical processes, procedures and programs. Lastly, the role will ensure that project/department milestones and goals are met, adhering to approved budgets. Key part of this role is to coordinate the study execution in collaboration with internal team, CROs and contractors. This is an exciting opportunity to help build our company narrative and collaborative partnerships with key opinion leaders and investigators. This position is Temp to Hire. Principal Responsibilities: - Drives global Clinical Trial activities pertaining to study-level strategy, timelines, quality and execution of clinical studies - Proactively identifies, problem solves and manages risks to trial execution and quality, implements corrective actions, and ensures inspection readiness at all times - Supports the development of clinical study protocols and reports, ensuring studies are conducted in accordance with accepted scientific standards, meet relevant regulatory requirements and are conducted within ethical guidelines - Drives development and execution of operational activities outlined in various study plans, SOPs, study procedures, etc. - Ensure adherence to FDA and GCP guidelines as well as other appropriate regulatory bodies as required - Coordinates the development and distribution of critical study documents (ICFs, operational/training documents, reference documents, newsletters, site materials, etc.) and manages the TMF, as needed - Drives study start-up, subject enrollment plan, clinical monitoring activities, clinical site compliance and data metrics from CROs and/or investigators, central labs, and other external vendors as required - Communicates trial status by tracking clinical study metrics to ensure cross-functional alignment on expectations, priorities, and deliverables - Represents MannKind, from a clinical perspective, building strong relationships with clinical trial sites including investigators and study staff - Plans, facilitates, and monitors training at investigator meetings, kick-off meetings, and various CRO/vendor meetings - Demonstrates budget accountability by tracking vendor performance against SOW, contracts and invoices to ensure consistency between work performed and contractual agreements - Partners with Supply Chain to provide oversight and accountability of the applicable study drug(s), including supply projections, distribution, labeling and destruction - Collaborates in the program-level development of clinical strategies, goal-setting, and establishment of timelines Required Skills and Experience: - BS/BA +12 / MS/MBA 8-10, PhD 5+ - 5+ years direct clinical trial global experience (phase 2-3 preferred) - Equivalent combination of education and applicable job experience may be considered - Relevant industry (biotech or pharmaceutical) experience - Knowledge of pulmonary orphan diseases and associated medical terminology - Knowledge of Good Clinical Practices (GCP) and associated FDA regulations governing human subject protection and the conduct of clinical trial (IRB, IND, etc.) - Proven experience in the oversight of the operational aspects of clinical studies, preferably in a global environment - Exhibits the ability to recognize the need to seek assistance from or inform Senior Management of specific risks/issues; understands when decision making can occur at the study team level versus when there is a need for escalation - Ability to organize and manage multiple priorities - Excellent oral and written communication skills - Solution-focused, comfortable with ambiguity, and an organized self-starter - Strong attention to detail in a fast-paced, evolving environment - Works effectively in both individual and team-based settings, with a high sense of urgency - Strong interpersonal skills and ability to build relationships with stakeholders at all levels - Willingness to travel up to 25% of the time #LI- Remote #LI-Onsite

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity • Oversees site interactions post activation through site closeout • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT) • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters. • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. • Participates and presents in key meetings such as Kick Off Meeting. • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. • Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. • Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. • Ensures access and audit trail reviews are conducted as required. • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. • Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. • Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans. • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. • Document requested revisions and approvals in CTMS. • Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. • Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. • Provides solutions for obstacles in protocol execution and site management. • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. • Supports Inspection Readiness for clinical trial management scope. • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. • May develop and support execution of corrective action plans at site and study level. • Supports and completes activities to achieve data cut and lock deadlines. • Provides feedback to line managers on staff performance including strengths as well as areas for development. • May be assigned to larger,more complex trials.