Title: Clinical Operations Manager - Dallas, TX Location: 8144 Walnut Hill LN, STE 1350 Dallas, TX 75231 950 E Belt Line RD, STE 190 Cedar Hill, TX 75104 6121 N State HWY 161, STE 120 Irving, TX 75063 1005 W Ralph Hall PKWY, STE 227 Rockwall, TX 75032 Department: Clinic Job Description: VIVO Infusion - Clinical Operations Manager Dallas, TX Vivo Infusion, LLC is looking for a dynamic Clinical Operations Manager with a passion for team building, leadership, and quality patient care to support our regional growth in the Dallas, TX area! The area Clinic Manager will support the clinics in their region both in person and remotely. The person in this role will be responsible for overseeing all patient care activities, daily clinical operations, ensuring a safe and efficient environment while adhering to budgetary expectations and regulatory functions as outlined by the State, Federal, JCAHO, additional accreditation agencies, and Vivo company policies. If you are passionate about providing the highest level of quality patient care, have a strong background in leading clinical teams, and have a current TX State Nursing or Advanced Practitioner License, we'd love to hear from you! Compensation: - Pay Range: $100,000.00 - $105,000.00/Year - Bonus Plan Target: 10% - Private Equity for the Greater Good - Company-wide Employee Ownership Program Benefits: - Medical, Dental, Vision - HSA w/ Employer Contribution - Touchcare - Insurance Concierge Service - 401K with Match up to 4% - PTO: Accrual 3+ weeks - PTO Buy-back, PTO Rollover, and PTO Donation Program. - Wellness Reimbursement Program - $360 Annually - Employee Referral Bonus - Uncapped Bonus Potential - Tuition Assistance Program & Professional Association Reimbursement - Employee Assistance Program (Employer-provided) - Short & long-term disability (Employer-provided) - Life Insurance (Employer-provided) Employment Type, Schedule, FLSA Status: - Full-time - Monday - Friday | 8:00am - 5:00pm - Weekend Clinic Coverage - One Work from home day per week - Non-Exempt Reports to: VP Operations Locations: - 8144 Walnut Hill LN, STE 1350 Dallas, TX 75231 - 950 E Belt Line RD, STE 190 Cedar Hill, TX 75104 - 6121 N State HWY 161, STE 120 Irving, TX 75063 - 1005 W Ralph Hall PKWY, STE 227 Rockwall, TX 75032 Primary Responsibilities: - Oversees and manages patient care and clinical operations within assigned regional locations. - Upholds company policies, procedures, mission, values, and expectations. - Executes protocols and quality initiatives to improve clinical outcomes and patient experience of care. - Directly oversees teams of Advanced Practitioners, Registered Nurses, Medical Assistants, Administrative Assistants, and other clinical staff licensed and unlicensed. - Responsible for directly managing all team members, including holding consistent 1:1s, creating and upholding specific measurable goals, hiring, termination, evaluations, disciplinary process, documentation, and reporting within the guidelines of Vivo Company policy. - Develops and maintains effective communication and working relationships with external community partners, resources, staff, co-workers, physicians, and patients. - Budget management: Oversees labor costs and supply utilization. - Leads, coordinates, supervises, monitors, delegates, and documents all aspects of patient care activities. - Collaborates across departments and with all disciplines, utilizing internal and external resources to provide optimal patient care. - Ensures and coordinates training, growth, and development opportunities for all clinical team members. - Evaluate needs, develop, and uphold processes, policies, and procedures in accordance with industry standards, and JCAHO and/or other accreditation agency standards. - Responsible for the delivery of services to patients, ensuring compliance in the performance of all aspects of patient care in accordance with Vivo company policies and procedures, accreditation agencies, and State and Federal guidelines. - Manages patient and staff schedules to ensure optimal staff-to-patient ratios in accordance with the clinical census, operational goals, and regulations set forth by State and Federal agencies. - Serves as a member of the Quality Committee and infusion center Governing Body in conjunction with the Medical Director. - Acts as the Infection Control Manager of the infusion centers infection control surveillance activities. Additional responsibilities: - Manage and ensure appropriate documentation of nursing and Advanced Practice Provider processes, Assessments and Plans of Care, admission and monthly documentation is complete, and patients medical records are maintained in accordance with Company policy and regulatory agency requirements. - Schedules center audits including quality, medical records, fire & safety, and emergency preparedness. Delegates to appropriate personnel as needed. - Implement patient and staff satisfaction surveys and reports results to Quality Committee. - Completes reporting in a timely manner, including but not limited to, payroll, census, drug inventory log, and quality. - Reviews and approves clinic invoices, and direct report expense reports; performs and/or oversees the completion of all required month-end reporting. - Reviews billing and inventory reports daily to ensure all utilized drug is billed appropriately. Qualifications: Education, Certifications & Licensing: - Must be a Registered Nurse. Current and unencumbered State Nursing or Advanced Practitioner License, required. - Bachelor's Degree in a related field, preferred - RN with Associate's with leadership experience considered - 2-4 years of progressive healthcare management experience, required. - Valid Drivers License and insured reliable transportation to travel between facilities or other meetings, required. Experience and Skills: - Experience managing or supervising direct reports and business operations, required. - Experience managing or supervising direct reports in a multi-clinic setting, preferred. - Healthcare experience - 10 years - Leadership experience - 5 years - Must have demonstrated record of and commitment to safety; dedicated to clinical and customer service excellence. - Must possess outstanding communication and interpersonal skills. - Must be able to communicate professionally and effectively with other staff members, patients and physicians. - Proficient knowledge of computers, Microsoft Suite, CRM software, and database experience. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. WORK ENVIRONMENT & PHYSICAL DEMANDS: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. While performing the duties of this job, the employee is regularly exposed to work near moving mechanical parts (medical equipment and machinery). The employees may be exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually moderate. Specific vision abilities required by this job include close vision, color differentiation, distance vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is required to stand; walk and talk, hear and smell. Requires excellent visual acuity and manual dexterity. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms. He/she is frequently required to sit; stoop, kneel, bend, crouch, or crawl. The employee may be required to use safety equipment, PPE (personal protective equipment) that may include but not be limited to face shield or goggles, non-slip shoes, gloves, mask, and other protective garments and equipment. Who We Are: The Vivo Infusion team is focused on providing patients with the highest quality of care in a comfortable, safe, and convenient setting! Vivo is a national company with locations in 15 states, providing opportunities for growth and advancement as well as competitive benefits that support what matters most to you. Our highly trained medical professionals are dedicated to delivering a safe, comfortable, and affordable solution for our patients. We offer an array of advanced therapeutics and provide personalized care for every patient. We are passionate about providing high-quality patient care, relationships with our referring Providers, and nurturing our company culture! Vivo Infusion has received The Gold Seal of Approval from The Joint Commission. The Joint Commission Gold Seal of Approval is a nationally recognized distinction voluntarily earned by a select set of healthcare providers. An organization that achieves The Gold Seal of Approval shows its commitment to holding itself accountable to a high bar for quality and safety for those they serve. Work environment and physical demands: Applicants will never be asked to provide personal identification information (e.g., SSN, Drivers License, Passport) or financial information (e.g., Banking Information) during the application and Interviewing process. We may request: - Contact details such as name, address, email address, and phone number. - Employment history including previous employers and job titles/positions. - Background information including academic/professional qualifications, job qualifications, education, certifications or licenses, details included in your CV/resume, transcripts, and employment references. - Nominated references including their name, contact details, employer, and job role. - Proof of your eligibility to work in the US. - Desired salary.

• Responsible for the strategic and tactical operational planning and execution of R&D sponsored clinical programs • Responsible and accountable for planning, coordinating, overseeing, and conducting complex global clinical trials • Collaborate in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services • Accountable to plan, drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met • Lead (multiple) cross-functional teams and drive oversight of CRO’s and vendor management • Understand the different requirements of agencies related to the clinical packages and plans manages accordingly • Responsible for inspection readiness

• Responsible and accountable for planning, coordinating, overseeing, and conducting complex global clinical trials in one or more therapeutic areas. • Collaborate in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services. • Accountable to plan, drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations. • Lead cross-functional teams and drive oversight of CRO’s and vendor management. • Understand the different requirements of agencies related to the clinical packages and plans manages accordingly the different functions (i.e. CSR, TFLs, ISS etc.) • Responsible for inspection readiness. • Accountable for CAPAS related to clinical programs within the field of Clinical Operations. • Accountable and responsible for the financial planning, budget, accruals, forecasts contribution. • Preparing clinical program updates and/or contribution to them as needed.

Role Description We are searching for the best talent for Clinical Site Manager. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. This is a remote role available in all states/cities within The United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. Responsibilities - Serve as Subject Matter Expert (SME) for monitoring and site management activities conducted on assigned clinical studies. - Review of study level trends, escalations, and action items to ensure overall site management efficiency. - Review monitoring visit reports to ensure compliance with Abiomed procedures and study plans. - Serve a critical role as liaison and facilitate meetings between project stakeholders to ensure study tasks and deliverables are on track. - Provide direction and guidance to execute project deliverables in collaboration with project/program managers. - Provide strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site). - Act as a Core Team lead, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form. - Determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. - Lead in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements. - Train and proctor new employees on trial and study related activities. - Resolve complex trial/study data and regulatory documentation discrepancies escalated by junior level employees. - Develop Clinical Research Associates to increase business acumen and functional skills; act as a mentor to new or junior level employees. - Support the development of site training, recruitment, and required study related content and materials. - Support CRAs through study start up process, ensuring collection of appropriate documentation and timely review of documentation including but not limited to budgets, clinical research agreements and informed consents. - Participate in development and validation of case report forms, when applicable. - Review and complete checklist on informed consent forms (ICF), as needed. - Develop a familiarity with the protocols to ensure adherence to study timelines, inclusion and exclusion criteria, and enrollment goals. - Support of review of Standard Operating Procedures (SOPs); Work Instructions and engagement in process improvement initiatives. - Support conduct of Site Initiation Visits; train site personnel on sponsor and regulatory requirements for study conduct. - Participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation. - Support conduct of Site Monitoring (Site Management or Interim Monitoring Visits) Visits and follow-up to identify significant problems and issues. - Ensure that all clinical aspects of studies are being carried out in accordance with study. - Support conduct of Site Close-out Visits and follow-up to ensure all site related activities and documents are complete and filed in the eTMF. - Develop tools, trackers, and project specific training materials. - Assist in the auditing of clinical trials. Qualifications - Bachelor's Degree or equivalent in science-related field with at least 5 years previous field monitoring experience. - 2-3 years in a Lead CRA or project management type of role. - Experience with electronic data capture and Clinical Trial Management Systems required (Veeva Vault CTMS/eTMF and Medidata/Rave EDC preferred). - Prior experience supporting trials for Class II/III medical devices. - Familiarity with quality assurance/control processes and regulatory compliance. - Proven expertise in MS Office Suite, including Word, Excel, and Adobe. - Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives. - Excellent problem-solving, organizational, analytical, and critical thinking skills. - Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA/Project Management certification) preferred. - Master's Degree or equivalent with Experience working in a regulated industry preferred. - Ability to travel up to 50% (throughout the US), as required. Benefits - Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Consolidated retirement plan (pension) and savings plan (401k). - Annual performance bonus based on individual and corporation’s performance. - Vacation – up to 120 hours per calendar year. - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year. - Holiday pay, including Floating Holidays – up to 13 days per calendar year. - Work, Personal and Family Time - up to 40 hours per calendar year.