• Participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations department. • Act as preliminary liaison for study sites to convey study information, answer questions and in accordance with the escalation pathway. • Develop relationships with investigational sites, HCPs, and institutions to enhance conduct of the trial. • Monitor study-specific timelines and key deliverables; focus on management of all relevant external vendors (e.g., Monitoring, Sample management, IVRS, Laboratory, etc.). • Participate as a member of the multi-disciplinary trial(s) team. • Participate in coordinating efforts with internal Pharmacovigilance, and safety group as needed. • Participate in data review and discrepancy resolution as needed. • Assist in the development of the IP and co-medication strategy (quantities, labels, depots, tracking, etc.) working closely with other departments. • Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety call, etc.) as appropriate. • Assist in the development and management of study timelines and priorities, including recruitment tools/strategy. • Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization as appropriate. • Participate in the feasibility and evaluation of investigative sites as needed, working closely with the Clinical Trial Logistics group. • Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). • Update template for new risks and new amendments information. • Assists in the review, development and writing of study documents and manuals, including but not limited to study manuals, treatment guidelines, patient access forms, laboratory or biomarker plans, and other supporting documents.

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details Essential Duties: - Territory management for existing TEG customer base. - Increase product usage at existing accounts and expand customer base through clinical education of new users and generate revenue growth. Ensure customers are able to independently, safely and efficiently operate TEG equipment, software, and related disposables as well as interpret the TEG results in the many applications of use. - Train new and existing customers on all product and clinical aspects of TEG line. Provide summary of training sessions and ensure follow up as needed through onsite support in the many areas of operation and application such as lab, critical care, and OR. - Provide clinical expertise to help ensure that our TEG product line reaches standard of care levels within the account, leveraging our CRM tool and market data. - Help drive and expand existing business to include broadening application of our TEG within the account, achieving assigned sales AOP annually, by ensuring all applicable TEG assays and most updated software versions are being utilized to maximum effectiveness. This is achieved by developing new relationships with clinicians, further cultivation of existing relationships, didactic education provision and grand rounds presentations, case support, taking calls from the end users, and hosting market development events. - Visit assigned hospital accounts, identify and train clinical champions and establish relationships with key decision makers. - Provision of dedicated onsite support for new TEG customers “going live” with the technology or additional assays inclusive of all affected shifts and areas of use case support and training inclusive of after-hours support. - Resolve technical, operational, and clinical customer concerns through accurate and timely investigation and partner with cross-functional team members to develop solutions. - Increase professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks and participating in professional societies and conferences. - Provide history by maintaining records within CRM tool on area of responsibility and customers in that area. - Support VAD/ECMO customers, Trauma, CV, High Risk Obstetrics, Liver transplant, Vascular, and all Critical Care clinicians in their use of TEG. - Assist customers in tailoring their products training materials and needs. - Understand competition and competitive landscape in existing territory, and convert to TEG business in existing accounts. - Work closely with Account Manager in overlapping market to target key accounts for expansion and forecast revenue increase during quarterly business planning and monthly cadence calls with management. - Provide tradeshow support, both regionally and nationally. - Drive demand for device and software upgrades as well as add on devices. - Work closely with Account Manager and Implementation team during laboratory installation, validation, and verification process including assistance with training, competency, SOP and IQCP development, normal donor sourcing, logistics support for TEG program, and ordering/interfacing needs. - Prospect and develop multi-level relationships (including C-level) within defined territory. - Participate in product development market needs and/or quality investigative needs and launches while providing feedback to sales, marketing and R&D Supervisory Responsibilities: None Qualifications: Education Level: - Bachelors of Arts or Science (required) - Masters of Arts or Science or Business Administration (preferred) Education Detail: - Science or medical related profession Years of Experience: 3+ Experience Details: - Industry or clinically related experience, preferably in complex medical devices and/or critical care environment. Skills: - Demonstrated written communication skills - Strong verbal communication and listening skills - Ability to convince and proven experience in driving products adoption. - Effective interpersonal skills, Comfortable in interacting with clinicians at a high level and with a flair for developing customer relationships. - Strong Project management skills and solid organization skills - Knowledge of hemostasis management required - Strong technical/clinical aptitude to understand, train customers and users on products (including running the TEG® Analyzer, understanding application of results and manipulating the software) Physical Demands: Frequency: Never - Sitting; remaining in a seated position. - Standing; walking; reaching with hands and arms; and stooping, kneeling, crouching, or crawling. - Lifting/moving up to 10 pounds. - Fine manipulation; picking, pinching, or otherwise working primarily with fingers rather than the whole hand or arm as in gross manipulation. - Keyboarding; entering text or data into a computer or other machine by means of a keyboard. - Exposure to moving mechanical parts, vibration and/or moderate noise levels. - Exposure to hazardous chemicals or other materials. - Exposure to blood. Travel Expectations: Frequent Domestic: 50 - 75% EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics’ employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks’ vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. – 5 p.m. ET or email AskHR@Haemonetics.com. The base salary range for this role is: $84,700.00-$157,300.00/Annual

POSITION: The state of Indiana Clinical Provider (NP/IBCLC or PA/IBCLC) is responsible for ensuring direct patient care is evidence-based and aligns with SimpliFed's maternal health program requirements. Provider will conduct lactation-related clinical assessments, oversee remote patient monitoring, administer CPOE orders within scope of practice, and screen for maternal mental health. ROLE: The role of the Clinical Provider (NP/IBCLC) is expected to uphold the highest standards of care for the company and its patients. Providers will be required to engage in telehealth, virtual video, face-to-face appointments with patients to provide care and assist patients with their personal goals and those goals prescribed by their health care team(s). Providers are responsible for all clinical decision-making in alignment with SimpliFed's clinical protocols associated with the provision of Professional Services. VENUE: This role works full time remotely using SimpliFed approved devices. POSITION SUMMARY: The role of the SimpliFed Clinical Provider (NP/IBCLC) will conduct professional services consultations with patients via telehealth. Providers, based on their respective professional fields, will assess patients and provide education on topics such as lactation, infant feeding, hypertension, gestational diabetes, anemia, thyroid levels, and maternal mental health to name a few. Providers will document their findings in the exam form, provide proper resources to patients, and schedule patient follow up appointments, based upon need. Providers will make all necessary referrals to outside and referring providers based upon the need of the patient. REQUIREMENTS: - Master’s or Doctoral degree in respective clinical field (Nurse Practitioner) - Professional licensure in respective clinical field (Nurse Practitioner), in good standing with the governing board. - Professional certification as an International Board Certified Lactation Consultant (IBCLC) or Certified Lactation Counselor (CLC), in good standing with the governing board. - 3 years of direct clinical experience in hospital, clinic, or other healthcare setting with a minimum of 2 years experience as a CLC/IBCLC. - Active MMIS (State Medicaid) Credentials Preferred. - Interest in maternal health and improving outcomes. - Provide education and clinical support services to empower families to make informed decisions around baby feeding and infant care. - Ability to work independently and make sound decisions aligned with SimpliFed’s policies. - Strong active listening skills and sound judgment. - Demonstrated written and oral communication skills, as well as strong charting skills. - Knowledge of clinical workflows, healthcare quality and compliance standards, EHR data management, clinical documentation, HIPAA, and related regulations. - Ability to accept constructive feedback and make improvements to better serve SimpliFed patients, partners, and mission. POSITION SPECIFICS: - SimpliFed providers will see patients for a variety of matters in the maternal health and perinatal space. Services provided may include, but not limited to: - Lactation and Infant Feeding Services provided by IBCLC and CLC credentialed professionals. - Remote Patient Monitoring for Blood Pressure and Gestational Diabetes Nurse Practitioner, Physician Assistant, and Registered Nurse credentialed professionals. - Perinatal Mental Health provided by all SimpliFed providers and Credentialed Perinatal Mental Health Counselors (PMHC) - Other issues in the maternal vacuum of care such as, but not limited to, nutrition, anemia, thyroid issues. - SimpliFed Providers will communicate with patients via the company's electronic medical record system and virtual video platform. - SimpliFed Provider communications should focus on clinical relevance and empower patient health literacy and evidence-based decisions. - Review of patient’s intake forms, complete a history and virtual physical evaluation of the pregnant or postpartum patient. - Conduct Perinatal Mental Health Assessment using standardized assessment instruments and tools provided in the Exam Forms as well as general observation of a patient's current mental state. - Provide education on topic(s) associated with the appointment type. - Obtain relevant patient medical history using the intake form or other forms as defined by SimpliFed. - Complete Exam Forms in full, including, but not limited to, a record of the start and end times of the visit as well as relevant medical history, intake, baby wellness, diagnosis and procedure codes for the visit, by checking the appropriate boxes on the exam form - Complete Documentation of all events, observations, evaluations, assessments, and instructions relevant to the visit, the same day as the completed appointment. - Develop an individual Care Plan for each patient which includes written instructions, resources, and a plan for follow up. - Complete Referrals/Coordination of Care (if necessary) and send to the proper entity. - Scheduling subsequent appointments with patients prior to completing the current appointment. GENERAL EXPECTATIONS: - Be committed to the mission of the SimpliFed. - Excellent interpersonal skills to include working with fellow SimpliFed leadership and employees, external medical professionals, and patients. Social perceptiveness necessary. - Work within the scope of practice and remain compliant with the execution of clinical protocols, licensure, and credentialing. - Comply with SimpliFed’s availability requirements. - Ability to work with minimal supervision and maintain a high degree of communication of current work activity with supervisors. - Behave in a professional manner and consistently demonstrate and promote the values of respect, honesty, and dignity for the patient, providers, and all members of the healthcare team. - Committed to the constant pursuit of excellence and teamwork in improving maternal health by leading with empathy and compassion. - Successfully complete background check. - Maintain compliance with SimpliFed’s policies and prevailing Federal security and privacy regulations. WORK ENVIRONMENT: Work is performed virtually. Comfortable working with remote productivity communication tools is required.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Senior Clinical Project Manager (SCPM) reports to the Senior/Director of Clinical Operations who bears primary responsibility for the execution of Telix’s clinical trials. The SCPM is responsible for the successful execution of national and global clinical trials (early phase to registration) from protocol conception, start-up through the clinical study report, including all aspects of project document development, budget, safety, quality, and team management in an environment where problem solving, critical thinking, teamwork and flexibility are vital to success. The SCPM ensures completion of study deliverables and proactively identifies and resolves clinical project issues. - Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial timelines, budgets, resources, and vendor relationships from protocol finalization through to study closeout. - Forecast and identify opportunities to accelerate activities to bring spend forward or identify if spend will shift. - Independently develop integrated study management plans with the core project team. - Developing and managing all study-related documents such as study protocol, informed consent, clinical manuals, and implementing quality standards. - Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget. - Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs. - Managing risks proactively and leading problem solving and resolution efforts. - Support the development and maintenance clinical SOPs & trial process’ as required. - Developing project delivery strategy for RFPs. Lead in bid defense preparations. Understand project strategy and translate the agreed upon approach. - Management of complex multi-national, multi-center clinical research projects. - Develop patient recruitment strategies. - Conduct contract and budget negotiations with sites and vendors. - Communicate trial status, issues, and mitigations to leadership and relevant cross-functional stakeholders. - Train study team members and act as mentor for CPMs. - Work independently with limited supervision. - Attend medical conferences and represent clinical operations through investigator engagement and/or presentations. Qualifications - Bachelor’s degree in life sciences required, PMP preferred. - 5+ years of relevant experience in Clinical Trial Project Management required. - Experience with late phase clinical trials (Phase 3 - 4, registration trials), oncology and/or radiopharmaceutical experience preferred. - Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines. - Team oriented mindset and demonstrates ability to work with cross functional teams. - Experience managing global clinical trials. - Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes. - Demonstrated ability to pivot study strategy quickly and lead teams in the right direction. - Strong analytical, organisational, planning, decision making, negotiation, and conflict management skills. - Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in working in mainly electronic record-keeping environment. - Demonstrated leadership skills and ability to cultivate development of others. - Start-up experience (country and site feasibility, ethics & regulatory submissions in multiple regions (APAC, EMEA, NA)). Key Capabilities - Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected. - Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges. - Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do. - Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results. - Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders. - Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges. - Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language. - Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals. - Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges. - Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.