• Lead the end-to-end management of medical device clinical studies across multiple regions • Oversee study timelines, deliverables, and budgets, ensuring operational excellence • Collaborate with and manage CRO partners to ensure effective study execution • Contribute to protocol development, including defining study endpoints and methodology • Ensure compliance with applicable regulatory requirements, with a strong focus on medical device regulations • Manage submissions to ethics committees and relevant regulatory bodies • Oversee study documentation, including Trial Master File quality and end of study reports • Provide regional oversight across Africa and India, including on-site engagement as required

AffirmedRx is on a mission to improve health care outcomes by bringing clarity, integrity, and trust to pharmacy benefit management. We are committed to making pharmacy benefits easy to understand, straightforward to access and always in the best interest of employers and the lives they impact. We accomplish this by bringing total clarity to business practices, leading with clinical approaches, and utilizing state-of-the-art technology. Join us in improving health care outcomes for all! We promise to do what’s right, always. Position Summary: The Formulary Management Pharmacist plays a crucial role on the Formulary Strategies Team, by being responsible for developing and maintaining formularies as well as working cross functionally to ensure operational compliance. This position will lead Pharmacy and Therapeutics committee meetings, provide clinical recommendations across drug classes, develop utilization management protocols, and monitor the drug pipeline to forecast future formulary strategies. What you will do: - Remain current with industry trends and provide clinical intelligence to internal teams and clients - Monitor drug pipeline and assess new drugs to the market to determine appropriate formulary management strategies - Develop and present clinical material at Pharmacy and Therapeutics Committee meetings, ensuring clarity and relevance - Work closely with upstream and downstream partners on formulary decisions and updates - Analyze large data sets to identify utilization trends/outliers and implement appropriate utilization management edits - Investigate/resolve clinical issues and escalate issues to management as required - Collaborate with internal and external teams to support client inquiries and provide insight on drug spend, utilization, clinical alternatives, and formulary compliance - Assist in responding to clinical RFI and RFP questions - Communicate formulary changes, formulary status, and clinical benefit coverage to internal and external teams - Provide oversight of client specific formulary marketing materials - Work with analysts to oversee clinical edit/drug list development and ensure appropriateness of formulary and clinical benefit adjudication in claims processing system - Participate in implementation meetings and provide clinical and operational support for the transition of new clients over to AffirmedRx standard or custom formularies - Develop formulary management programs and cost savings initiatives - Ensure formulary is compliant with regulatory requirements - Develop and maintain department process documents What you Need: - Registered pharmacist, RPh or PharmD required - Active and unrestricted Pharmacist license - 3-5 years of managed care or PBM experience, preferred - Formulary management experience, preferred - Residency/fellowship completion, preferred - Ability to manage multiple projects at a time, required - Analytical thinking and strong problem solving abilities - Knowledge of pharmacy benefit design, drug utilization management, and healthcare regulations - Strong attention to detail and accuracy in data management - Effective communication and presentation skills to interact with cross-functional teams and clients - Proven time management, organizational, and multi-taking skills - Ability to work independently and collaboratively within a team - Proven commitment to high quality work - Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, etc.) - Willingness and ability to travel (10%-20%) What you get: - To impact industry change in the pharmacy benefits management space, while delivering the highest quality patient outcomes. - To work in a culture where people thrive because when OUR team thrives, OUR business thrives. - Competitive compensation, including health, dental, vision and other benefits. Note: AffirmedRx is committed to providing equal employment opportunities to all employees and applicants for employment. Remote employees are expected to maintain a professional work environment free of distractions to ensure optimal performance and collaboration.

Overview Guide Patients. Support Families. Navigate Post-Acute Care. We are seeking a Care Coordinator – Non Clinical to support our Care Coordination call center team. This work-from-home telephonic role helps patients and families navigate post-acute services, handles non-clinical inbound calls, escalates to nurses when necessary, and supports referral coordination for patients who may need Gentiva services. Reporting to the Contact Center Manager, this role operates under established performance criteria. As a Care Coordinator – Non Clinical, You Will: - Act as a Gentiva representative supporting patients discharged from service or seeking post-acute care - Navigate healthcare options, including post-acute offerings, Medicare coverage, billing, and other healthcare resources - Utilize tools and methods to provide patient education and options quickly, including sites of service, specialty offerings, and related questions - Handle a variety of customer issues, including location lookup, directions, and complaints - Assist in the admissions process by coordinating with Gentiva branch staff on patient admission status - Maintain awareness of department performance objectives, meet standards, and ensure patient satisfaction goals are met - Review and adhere to all company policies and procedures - Participate in special projects and perform other duties as assigned The shift is: Thur: 10:00am - 6:30 pm Fri: 3:30pm -12:00am Sat: 8:00pm - 8:30am Sun: 8:00pm - 8:30am Essential Functions This is a work from home position. To support operational needs and business hours, candidates should reside in one of these states: Alabama, Arkansas, Florida, Georgia, Indiana, Kansas, Michigan, Missouri, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas or Virginia. About You Qualifications – What You'll Bring: - Call center experience in a healthcare setting - Outstanding computer skills and ability to quickly learn and master information related to locations and services - Excellent verbal and interpersonal communication skills with empathy and professionalism - Strong customer service focus - Effective time management and organizational skills - Strong analytical and problem-solving abilities - Minimum of 1 year of experience in a healthcare-related field or healthcare call center - High-speed internet connection required (minimum 10 Mb/s download, 2 Mb/s upload; satellite internet not acceptable) Preferred Qualifications (Not Required): - Associate degree - Additional healthcare call center experience - Previous experience with Gentiva services or other hospice/home health organizations - Knowledge of home health, hospice, and palliative care services We Offer Benefits for All Associates (Full-Time, Part-Time & Per Diem): • Competitive Pay• 401(k) with Company Match• Career Advancement Opportunities• National & Local Recognition Programs• Teammate Assistance Fund Additional Full-Time Benefits: • Medical, Dental, Vision Insurance• Mileage Reimbursement or Fleet Vehicle Program• Generous Paid Time Off + 7 Paid Holidays• Wellness Programs (Telemedicine, Diabetes Management, Joint & Spine Concierge Care)• Education Support & Tuition Assistance• Free Continuing Education Units (CEUs)• Company-paid Life & Long-Term Disability Insurance• Voluntary Benefits (Pet, Critical Illness, Accident, LTC) Apply today to help guide patients and families through post-acute care navigation and support high-quality outcomes. Legalese - This is a safety-sensitive position - Employee must meet minimum requirements to be eligible for benefits - Where applicable, employee must meet state specific requirements - We are proud to be an EEO employer - We maintain a drug-free workplace Location Gentiva Our Company At Gentiva, it is our privilege to offer compassionate care in the comfort of wherever our patients call home. We are a national leader in hospice care, palliative care, home health care, and advanced illness management, with nearly 600 locations and thousands of dedicated clinicians across 38 states. Our place is by the side of those who need us – from helping people recover from illness, injury, or surgery in the comfort of their homes to guiding patients and their families through the physical, emotional, and spiritual effects of a serious illness or terminal diagnosis. Our nationwide reach is powered by a family of trusted brands that include: - Hospice care: Gentiva Hospice, Emerald Coast Hospice Care, Heartland Hospice, Hospice Plus, New Century Hospice, Regency SouthernCare, SouthernCare Hospice Services, SouthernCare New Beacon - Palliative care: Empatia Palliative Care, Emerald Coast Palliative Care - Home health care: Heartland Home Health - Advanced illness management: Illumia Health With corporate headquarters in Atlanta, Georgia, and providers delivering care across the U.S., we are proud to offer rewarding careers in a collaborative environment where inspiring achievements are recognized – and kindness is celebrated.

CRA II Location: Morrisville United States Job Description: Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities - Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: - Bachelor's degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills - Ability to manage required travel of up to 75% on a regular basis - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.