Title: Strategic Clinical Quality Manager - Minneapolis/St.Paul and surrounding areas - Minnesota Region Location: Minneapolis, MN, USA Full time - Remote Job Description: Position location: You will be able to work remotely, from your home location, in the United States This is a remote opportunity within the Minneapolis/St.Paul and surrounding operational areas! The individual selected must reside in the Minnesota region. Travel required! 80% Travel Required - multiple area assignments Position covers all 3 modalities PURPOSE AND SCOPE: The Clinical Quality Manager is responsible for developing, implementing, and monitoring quality assurance and performance improvement (QAPI) programs to ensure the highest standards of patient care and regulatory compliance. This role oversees clinical outcomes, coordinates quality initiatives, ensures adherence to regulations, and collaborates with the interdisciplinary team to drive continuous improvement in patient safety and clinical quality performance. The scope of the clinical quality oversight of the position covers assigned treatment modalities (e.g. in-center, home modalities, or home hemodialysis and home peritoneal dialysis) PRINCIPAL DUTIES AND RESPONSIBILITIES: - Lead or participate in the clinic’s Quality Assessment and Performance Improvement (QAPI) program in alignment with CMS, state, and organizational standards. - Develop and implement action plans to address deficiencies and improve care delivery. - Conduct regular audits and quality reviews to ensure compliance with clinical policies & procedures. - Facilitate staff education and training related to quality improvement, patient safety, and best practices. - Collaborate with physicians, nurses, dietitians, social workers, and leadership to support evidence-based clinical initiatives. - Prepare and present quality reports to clinic leadership and governing bodies. - Ensure accurate documentation, data collection, and reporting for internal and external stakeholders. - Promote a culture of accountability, safety, and continuous improvement within the clinic. - Manages the execution and achievement of Quality key performance indicators (assigned by Quality leadership team) and other clinical initiatives, interventions and standardized education materials with clinic teams within the assigned area(s). - Performs other related duties as assigned. PHYSICAL DEMANDS AND WORKING CONDITIONS: - The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. - Day-to-day work includes desk and personal computer work and interaction with facility staff and physicians. - The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials. - Field: The position requires travel between assigned facilities and various locations within the community, approx. 60%-80%. ○ Travel to Regional, Division and Corporate meetings may be required. - Remote: The position could require travel up to 10-15% SUPERVISION: - None EDUCATION AND REQUIRED CREDENTIALS: - Registered Nurse required - BSN or bachelor’s degree in healthcare-related field preferred (or equivalent experience). - Certification in Nephrology Nursing or quality preferred EXPERIENCE AND SKILLS: - 3+ years of dialysis experience required. - 2+ years' experience in a leadership role. - Strong organizational, critical thinking and customer service skills. - Demonstrated leadership competencies and adaptability to changes in priorities - Ability to work collaboratively with other members of the team, gain support and input while participating in quality improvement activities. - Strong verbal and written communications skills. - Ability to analyze and propose alternate solutions, assist in resolving sensitive to complex issues The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies. Annual Rate: $85,000.00 - $142,000.00 for Waltham, MA location Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance. If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors.

Title: Associate Director, TMF Operations Location: Needham, MA Job Description: Full Time Manager/Supervisor Salary: $184-$210k + bonus + options + benefits Hybrid role- 2-3 days in Needham office Why Work With Us? At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day. Our Science: Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.com Position Summary: We’re looking for an experienced Associate Director, Trial Master File (TMF) Operations to lead the Trial Master File operations across our oncology clinical programs. This role is ideal for someone who enjoys creating structure in a fast-paced biotech environment and can confidently partner across Clinical Operations, Quality, Regulatory, IT, and external vendors to ensure inspection readiness and operational excellence. You’ll play a critical role in strengthening TMF strategy, oversight, quality, and reporting infrastructure while helping build scalable processes that support a growing clinical portfolio. This is a highly visible opportunity for someone who combines strategic thinking with hands-on execution and enjoys driving continuous improvement. What You’ll Do: • Lead TMF operational strategy and help build scalable, inspection-ready processes across ongoing and future clinical studies • Drive oversight of electronic TMF activities to ensure quality, completeness, accuracy, and regulatory compliance across internal teams and external partners • Develop and refine TMF standards, governance models, workflows, and procedural documentation aligned with industry best practices and global regulations • Act as a trusted TMF subject matter expert and strategic partner to Clinical Operations leadership and cross-functional stakeholders - Management of the eTMF system vendor • Establish and monitor TMF health metrics, dashboards, and operational KPIs to identify trends, risks, and opportunities for improvement • Conduct TMF reviews, quality assessments, and operational audits to ensure inspection readiness at all times • For outsourced studies, partner closely with CROs and vendors to ensure deliverables, timelines, expectations, and performance standards are consistently met • Support implementation, optimization, and integration of TMF-related systems and technologies including eTMF platforms, CTMS, EDC, and other clinical systems • Collaborate with IT and business stakeholders on system enhancements, upgrades, validation activities, and change management initiatives • Help drive operational excellence by identifying process gaps, improving workflows, and creating sustainable solutions that support organizational growth • Provide training and guidance to internal teams on TMF processes, expectations, and best practices • Support clinical trial disclosure and registry compliance activities in partnership with cross-functional teams What You Bring: • Bachelor’s degree in a scientific, healthcare, or related discipline, or equivalent industry experience • 10+ years of clinical research experience within biotech, pharmaceutical, or CRO environments • Strong background in TMF operations, document management, and inspection readiness activities • Hands-on experience managing eTMF systems and TMF reporting processes • Deep understanding of ICH-GCP requirements, TMF best practices, and global regulatory expectations • Experience working collaboratively with CROs, vendors, and cross-functional stakeholders in a matrixed environment • Ability to operate effectively in a growing biotech company where priorities may evolve quickly • Strong organizational skills with the ability to manage multiple priorities while maintaining exceptional attention to detail • Excellent communication, collaboration, and problem-solving skills • A proactive mindset with the ability to work independently, influence others, and drive initiatives forward Work Environment: • Hybrid role based in Needham, MA • Regular onsite collaboration expected approximately 2–3 days per week depending on business needs • Occasional travel may be required to support audits, inspections, vendors, or cross-functional meetings You must be authorized to work in US. We are unable to provide any sponsorship at this time. NOTE: We are not allowing agencies at this time.

• Own the implementation and ongoing refinement of Karoo Health care model • Translate evidence-based cardiology guidelines into practical and scalable care protocols • Test, iterate, and standardize care protocols to meet the needs of individual markets and payer arrangements • Ensure the Karoo Health care model supports value-based care • Operationalize the clinical model across care teams, developing SOPs, staffing models, role definitions, and training materials • Identify operational bottlenecks or clinical variation and drive continuous improvement initiatives • Support market launches by ensuring clinical readiness, workflows, and staffing are in place • Provide operational support to Karoo’s clinical team (RNs, LCSW, MAs, etc.) • Support hiring, onboarding, training, and performance management of clinical staff • Foster a culture of patient-centered, data-informed, high-quality care delivery • Partner with Analytics and Finance to define and monitor clinical KPIs tied to value-based contracts • Use data to assess clinical effectiveness and identify opportunities to improve outcomes and reduce avoidable utilization • Collaborate with partner cardiology practices to ensure smooth integration of Karoo’s clinical model into existing workflows • Ensure clinical operations meet regulatory, licensure, and quality standards across states and care settings • Work closely with Product to inform clinical requirements for tools, workflows, and dashboards • Partner with Market Ops, and Growth teams to align clinical delivery with expansion goals

Role Description The Clinical Operations Manager (COM) for Peripheral Nerve Stimulation Therapy is responsible for leading a national team of Field Clinical Managers to drive clinical excellence, patient support, and sales enablement for the PNS Therapy product portfolio. This role blends clinical leadership with operations management, field service operations, and customer engagement, ensuring optimal patient outcomes while maximizing operational efficiency and customer satisfaction. - Hire, coach, and develop a national team of Field Clinical Managers - Implement engagement, retention, and development plans to ensure a highly motivated team, reduced turnover, and continuous employee growth - Conduct regular field observations (case coverage, ride-alongs, OR/clinic support) - Drive a culture of accountability, customer focus, continuous improvement, and operational discipline - Collaborate with sales leadership to develop and execute account strategies, including new customer onboarding and growth initiatives - Ensure delivery of high-quality clinical support for PNS procedures, including adherence to protocols, regulatory requirements, and patient safety standards - Build systems and processes that enable efficient clinical coverage and operational consistency - Ensure timely and efficient case coverage through optimized clinician deployment and capacity planning based on current and future-state business needs - Oversee workload balancing, staffing models, and territory alignment to maximize utilization and minimize inefficiencies - Establish and enforce clinical competency frameworks, training programs, and certification processes - Participate in customer education events, cadaver labs, and workshops - Ensure adherence to regulations, policies, and code of ethics Qualifications - Bachelor’s degree required; advanced degree preferred - 7+ years of experience in medical devices, including field clinical roles - 2+ years leading a field-based team in service delivery or clinical support - Implantable, wearable, or programmable medical device experience preferred - Experience in surgical/procedural and OR-based environments - Demonstrated success in clinical operations and continuous improvement - Strong coaching and performance management skills - High emotional intelligence and adaptability in clinical environments - Excellent communication with physicians and executive stakeholders - Strong cross-functional collaboration skills Requirements - This is a remote position requiring 50% or more travel - Proximity to a major airport in the Eastern or Central time zone is a plus Company Description Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.