When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. At Parexel FSP people make the difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world. Our employees have the opportunity to do meaningful things globally while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading growth potential. Parexel FSP is recruiting for a Manager, Clinical Operations based in Romania or Serbia. Home based role. Dedicated to a single sponsor. You will be responsible for the execution of study-level activities including but not limited to creating and updating trial-specific documents, vendor oversight & delivery, compound training and country and regional oversight of CRO operational delivery. This includes alignment on the feasibility strategy, target setting, risk reviews, and country challenges that could impact overall study delivery. We will offer you exceptional financial rewards, training, and development. Expect exciting career challenges, but with a healthy work-life balance. We value your well-being as much as that of our patients. Tasks on the role - Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge. - Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specified studies - Provide input into global subject/patient recruitment plans. - Relationship management between study sites and vendors - Manage aspects of CRO/vendor identification and the day to day operational management activities of CROs & other vendors including set up, statement of work creation and budget oversight. - Manage strategic study operations including: study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc. - Create and update critical trial-specific documents (for example country specific ICF) and plans - Support development of compound and protocol level training materials - Review and provide input into budgets, timelines, and forecasts for assigned clinical studies - Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Clinical Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups. - Provide support for inspection readiness activities and on identification of risks and mitigation plans at the trial level - Participate in process improvement activities at a trial and department level as needed - Support onboarding of new team members - Attend CTWG and provide input and updates on operational activities and progress - Ability to travel (approximately10% but flexibility to go over or below as per business need. Requirements: Knowledge, Experience and Skills: - 5+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials. - 2-3+ years leading aspects of global clinical trials (working as CTM, COL or similar) - Experience working with a CRO - Experience in Cardiovascular is a big plus - Strong regulatory knowledge, including Good Clinical Practices (GCPs) - Strong decision-making, analytical and financial management skills are essential to this position - Proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision - Experience in leading without authority and in multifunctional matrixed and global environments - Experience mentoring/ coaching others - Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability. - Strong project planning/ management, communication (written and verbal) and presentation skills - Experience with protocol, ICF, CRF, CSR development and review. - Proficient with MS Office Suite (Excel, Word and PowerPoint) Education: - BS/ BA Degree is required. For more details contact marta.kuniewicz@parexel.com

Title: Director, Clinical Operations, Oncology Location: Massachusetts - Virtual Job Description: Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Director, Clinical Operations, Oncology based remotely reporting to the Executive Director, Clinical Operations, Oncology. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. Here, you will be a necessary contributor to our inspiring, bold mission. GOALS: - Lead and direct the execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU). - Responsible for line management and provides expert counsel for issue resolution, including programs assigned to other staff, when required. - Provide Clinical Operations leadership under the direction of the Senior Director, Clinical Operations: - Accountable for the overall execution of the assigned clinical program(s) with focus on quality, budget and timelines. - Accountable for the oversight of Strategic Partners and other vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. - The assigned clinical program(s) will be large, complex, high risk and/or of business importance to Takeda or potentially a suite of programs, requiring multi-functional leadership experience and skills to achieve program goals. If a single program is assigned, the program will typically be significant in scope (e.g., multiple independent indications with individual Clinical Sub Teams (CSTs)). ACCOUNTABILITIES: - Oversee COPLs assigned to represent Clinical Operations as members of the Global Program Team (GPT) and/or CST, working closely with GPT Leadership to ensure program objectives are met. - Represent Clinical Operations for assigned program(s) in issue escalation/awareness with senior management, e.g. functional or regional executive staff, PRC, alliance governance committees. - Contribute to the Clinical Development Plan(s) and associated operational strategy, in support of the Asset Strategy. - Accountable for program budget planning and external spend related to program execution and works closely with Global Program Management, and Finance to ensure financial accuracy. - Ensures communication of program status, cost and issues to inform timely decision-making by senior management. - Oversight of Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees; accountable for operational risk management strategy in collaboration with Strategic Partners. - Accountable for inspection readiness and provides appropriate guidance to COPLs/COMs in support of inspection activities - Collaborates with and is responsible to the Senior Director, Clinical Operations to ensure adequate clinical operations resources are assigned to program(s). - Demonstrate advanced Takeda Leadership Behaviors and act as a role model for Takeda´s values. - Recognized as a clinical operations expert by other functions and ability to represent and lead cross functional initiatives. - May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence. EDUCATION AND EXPERIENCE: - Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable. - 12 or more years’ experience in pharmaceutical industry, including 9 or more years in clinical study management. - Experience must include early phase experience or Phase 2 and 3 studies and global/international programs. - Oncology experience is required. - Experience in more than one therapeutic area and in line management is advantageous. Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals. - Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. - Supervisory experience. - Demonstrated excellence in project/program management and matrix leadership. - Excellent teamwork, organizational, interpersonal, and problem-solving skills. - Fluent business English (oral and written). - Able to influence without authority. - Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo. - Pragmatic and willing to drive and support change. - Is comfortable with ambiguity. - Support a culture of continual improvement and innovation; promote knowledge sharing. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 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

PURPOSE AND SCOPE: Develops, implements, maintains and evaluates an effective, data-driven, quality assessment and performance improvement program(s) with participation by other members of the interdisciplinary team. Serves as a quality improvement champion and role model by promoting and supporting the use of Continuous Quality Improvement (CQI) principles, methods, and tools to improve processes and patient outcomes at the facility and area levels. Must have effective communications among the interdisciplinary team (IDT) and must produce effective quality assessment and performance improvement activities which positively influence the assigned dialysis clinics clinical quality outcomes. The scope of the clinical quality oversight of the position covers all treatment modalities (e.g. in-center, home hemodialysis and home peritoneal dialysis), and in collaboration with the IDT, is responsible for the monitoring data/information; prioritizing areas for improvement; determining potential root causes; developing, implementing, evaluating, and revising plans that result in improvements in clinical quality outcomes in dialysis facilities within a geography. PRINCIPAL DUTIES AND RESPONSIBILITIES: - Facilitates the implementation and integration of the FKC Quality programs and initiatives into the facilities' standard operating procedures through teamwork and collaboration with area and facility clinical, interdisciplinary and operations teams. - Serves as a subject matter expert for clinical quality matters when collaborating with other RNs and members of the Area Quality Team. Identifies clinical quality improvement opportunities in the assigned area to achieve CMS Conditions for Coverage and FMS quality program requirements. - Manages the tactical execution of Quality and other clinical initiatives, interventions and standardized education materials with facility RNs within the assigned area. - Provides general direction, nursing and clinical guidance related to appropriate theoretical perspectives and feedback based upon professional standards and FMCNA guidelines to support facility RNs within the assigned area in achieving the desired outcomes in the following: quality, patient satisfaction, teamwork, unit culture, and employee satisfaction. - Collaborates with appropriate stakeholders including but not limited to the Clinical Quality leadership, Education, Clinical Services, Regulatory and Compliance to take the appropriate steps to facilitate achievement of quality goals and ongoing patient safety improvement. - Mentors and trains staff to collect, trend, and analyze data on a day to day basis to monitor the effectiveness of their clinical and operational processes to impact patient centered care resulting in improved patient outcomes and satisfaction and decreased morbidity and mortality. - Utilizes evidenced based and best demonstrated practices to address barriers to quality improvement. This includes promoting the adoption and utilization of Corporate Medical Advisory Board Recommended Algorithms and Standing Orders, clinical pathways and clinical policies and procedures to improve care coordination and care delivery. - Leverages available tools, resources and informatics technology to focus on targeted patient populations. - Applies current knowledge of FMS clinical and administrative policies and procedures, available internal resources, working knowledge of CMS Conditions of Coverage for ESRD facilities, Value Based Payer Programs, knowledge of quality improvement concepts, principles and practices to perform tasks and duties. - Utilizes quality improvement techniques to promote collaboration between facilities and areas to share processes and strategies for success. Mentors and assists facilities in identifying effective practices applicable to their needs, in testing for desired results, and the adoption and implementation of these practices. - Under the direction of Clinical Quality leadership, provides guidance, interpretation and subject matter expertise to clinical and operations teams regarding quality related clinical policies and procedures, clinical standards, quality improvement tools and electronic applications. - Performs desk review of facility Quality Assessment and Performance Improvement (QAPI) documentation and attends QAPI meetings at a frequency determined by Clinical Quality leadership. Collaborates with facility management staff to evaluate the effectiveness of the facility QAPI Program and CQI activities utilizing the following processes. - Reviews completion of facility QAI activities including but not limited to adherence to the QAI calendar, completion of QAI tools and electronic applications - Attends and participates in regional, area, facility and team meetings as appropriate which may include quality team building and staff development and other meetings as appropriate. Collaborates with appropriate management staff as needed to achieve effective inter-disciplinary, intra-disciplinary and clinic relationships. - Identifies risk areas and opportunities for improvement. - Assists with root cause analysis and action plan development and evaluation as needed. - Provides written or verbal recommendations to facility and area management. - Utilizes adult education principles in the execution of education programs and processes that facilitate the implementation and incorporation of the company's quality standards and the practice of Continuous Quality Improvement in facility standard procedures. - Accountable for outstanding customer service to all external and internal customers, including patients, staff, physicians, field management and staff, and payers, including disease management entities. - Develops and maintains exceptional working relationships through effective and timely communication with all customers - Under the direction of Clinical Quality leadership, assists with various projects as assigned. - 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 accommodations 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. - The position requires travel between assigned facilities and various locations within the community, approx.. 40-60%. Travel to Regional, Division and Corporate meetings may be required SUPERVISION: - None EDUCATION AND REQUIRED CREDENTIALS: - BSN or Bachelor's Degree in healthcare related field preferred or an equivalent combination of education and experience - Registered Nurse required - Certification in Nephrology Nursing or quality preferred. EXPERIENCE AND SKILLS: - 3+ years dialysis experience required - 3+ years management experience in a clinical 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 Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws. 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