Clinical Data Coordinator remote jobs

Clinical Trials Data Coord - (10032673) Description Clinical Trials Data Coordinator - RemoteJoin the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today. This full-time remote position entails ensuring data integrity for various research studies. Responsibilities include data abstraction, CRF completion, query resolution, sponsor monitor visit coordination, and maintaining audit-ready data. You will also oversee electronic research records and patient information in the CTMS, contributing to cutting-edge clinical research. As a successful candidate, you will: Possess in-depth knowledge of Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, NIH guidelines, and HIPPA regulations. Collaborate effectively as a valuable member of the clinical research team, demonstrating clear and timely written and verbal communication skills, including the sharing of critical information. Take responsibility for communicating any protocol deviations or issues related to study execution, ensuring transparency and problem resolution. Maintain strict adherence to study protocols by comprehending, communicating, and overseeing the proper execution of study parameters in accordance with protocol requirements. Seek appropriate supervision, when necessary, prioritize tasks effectively, consistently meet deadlines, and exhibit meticulous attention to detail in all aspects of your work. Qualifications - External Qualifications Your qualifications should include: Bachelor's Degree, relevant experience may substitute for degree. At least two years of experience related to the conduct of oncology clinical trials. Working knowledge of clinical trials, Federal, State, and Local Regulations, and IRB requirements. City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here. To learn more about our Comprehensive Benefits, please CLICK HERE. Primary Location: United States-California-DuarteJob: Clinical ResearchWork Force Type: RemoteShift: DaysJob Posting: Dec 5, 2025Minimum Hourly Rate ($): 29. 489500Maximum Hourly Rate ($): 45. 709000

Be a part of a world-class academic health-care system at UChicago Medicine as a Clinical Data Analyst - Same Day Surgery/Observation Coder. This is a remote, work from home opportunity and you may be based outside of the greater Chicagoland area. In this role, the Clinical Data Analyst - Same Day Surgery/Observation Coder, under general direction, is responsible for coding and abstracting diagnoses and procedures from inpatient and outpatient medical records for optimal and timely reimbursement and quality reporting. Essential Job Functions * Assigns ICD-10-CM/PCS codes and assigns DRGs for inpatient medical records accounts; assigns ICD-10-CM/PCS codes and CPT codes for outpatient medical record accounts * Abstracts key data elements required for billing * Reviews records for clinical pertinence * Interacts with providers for clarification of documentation/education * Abstracts and codes records, for patient currently in the Hospitals, for interim billing purposes * Reviews records according to pre-established criteria for referral to physician reviewers * Communicates with the medical staff to ensure appropriate assignment of principal and secondary diagnoses and procedures * Maintains CE credits in accordance with the American Health Information Management Association's requirements Required Qualifications * Associate or bachelor's degree * Certification as a Registered Health Information Technician (RHIT), Registered Health Information Administrator (RHIA) or Certified Coding Specialist (CCS) * Must have thorough working knowledge of ICD-10CM/PCS and CPT coding systems, DRG systems and federal/state regulations regarding reimbursement * Must have a thorough working knowledge of the hospital information system, electronic medical record systems and encoder; must have working knowledge of JCAHO standards for chart completion * Must have a working knowledge of medical-legal rules and regulations that govern the confidentiality and release of medical information with the ability to interpret and implement the standards; must maintain total confidentiality of all patient records; and PC experience Position Details * Job Type/FTE: Full Time (1.00 FTE) * Shift: Days - 8-Hour Shift * Location: Remote * Unit/Department: Medical Records * CBA Code: 743 Clerical Why Join Us We've been at the forefront of medicine since 1899. We provide superior healthcare with compassion, always mindful that each patient is a person, an individual. To accomplish this, we need employees with passion, talent and commitment… with patients and with each other. We're in this together: working to advance medical innovation, serve the health needs of the community, and move our collective knowledge forward. If you'd like to add enriching human life to your profile, UChicago Medicine is for you. Here at the forefront, we're doing work that really matters. Join us. Bring your passion. UChicago Medicine is growing; discover how you can be a part of this pursuit of excellence at: UChicago Medicine Career Opportunities UChicago Medicine is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, ethnicity, ancestry, sex, sexual orientation, gender identity, marital status, civil union status, parental status, religion, national origin, age, disability, veteran status and other legally protected characteristics. As a condition of employment, all employees are required to complete a pre-employment physical, background check, drug screening, and comply with the flu vaccination requirements prior to hire. Medical and religious exemptions will be considered for flu vaccination consistent with applicable law. Compensation & Benefits Overview UChicago Medicine is committed to transparency in compensation and benefits. The pay range provided reflects the anticipated wage or salary reasonably expected to be offered for the position. The pay range is based on a full-time equivalent (1.0 FTE) and is reflective of current market data, reviewed on an annual basis. Compensation offered at the time of hire will vary based on candidate qualifications and experience and organizational considerations, such as internal equity. Pay ranges for employees subject to Collective Bargaining Agreements are negotiated by the medical center and their respective union. Review the full complement of benefit options for eligible roles at Benefits - UChicago Medicine.

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Position Summary The Clinical Data Manager is an expert in clinical data management with demonstrated capability in building and maintaining clinical trial databases. They contribute to process improvements and initiatives within the Biometrics department as well as mentor and train junior staff members as applicable. Essential Functions Create and/or review study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards. Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner. Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, study requirements, and system best practices. Serve as a database manager for the study-specific clinical team, including the compilation of edit checks. Develop database requirements for use by EDC vendors. Serve as a study database manager and work with vendors to obtain deliverables in a timely manner. Create and/or review study-specific data management and database documentation, which may include: Data Management Plan CRF Completion Guidelines Coding Guidelines Annotated CRFs Edit Check Specifications Attend study-specific team meetings and produce status reports and requested metrics, which may include query information or data trends. Perform data review and query generation/closure. Perform coding of verbatim terms such as adverse events and concomitant medications. Collaborate with medical scientists for coding, consistency, review, and approval. Incorporating coding files into the clinical database. Participate in the development of new processes or revision of existing processes. Train internal colleagues in clinical data management in either informal or formal settings as needed. Train Investigators and/or Study Coordinators at Investigator Meeting on the CRFs, the EDC system, and the CRF completion guidelines as needed. Provide data management expertise and support to the clinical teams using data management best practices. Provide analytical insight into data management strategies and advise the internal team with tactical strategies accordingly. As necessary, provide work direction, guidance, mentoring, influence, and support to junior staff. Train junior staff in more complex clinical data management processes. Perform other special projects and duties as requested. Education & Experience Bachelor's Degree in a science-related field with 4+ years of experience; or High school diploma with 8+ year of relevant experience. 4+ years of clinical data management experience required. Experience working with EDC clinical databases required. Veeva Vault CDMS and TrialMaster experience preferred. MedDRA and WHO Drug coding experience preferred. Knowledge, Skills, & Abilities Working knowledge of clinical research, Good Clinical Practices, and regulatory requirements Knowledge of CDISC/STDM standards. Excellent English verbal and written communication skills; good organizational and interpersonal skills. Working Environment / Physical Environment This position works onsite or remote based on the candidate's location Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval. Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer Lift and carry materials weighing up to 20 pounds This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. National Market (all markets unless identified as Premium) $99,900 (entry-level qualifications) to $111,000 (highly experienced) annually Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $103,500 (entry-level qualifications) to $115,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Clinical Trials Data Coordinator - Remote Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today. This full-time remote position entails ensuring data integrity for various research studies. Responsibilities include data abstraction, CRF completion, query resolution, sponsor monitor visit coordination, and maintaining audit-ready data. You will also oversee electronic research records and patient information in the CTMS, contributing to cutting-edge clinical research. As a successful candidate, you will: * Possess in-depth knowledge of Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, NIH guidelines, and HIPPA regulations. * Collaborate effectively as a valuable member of the clinical research team, demonstrating clear and timely written and verbal communication skills, including the sharing of critical information. * Take responsibility for communicating any protocol deviations or issues related to study execution, ensuring transparency and problem resolution. * Maintain strict adherence to study protocols by comprehending, communicating, and overseeing the proper execution of study parameters in accordance with protocol requirements. * Seek appropriate supervision, when necessary, prioritize tasks effectively, consistently meet deadlines, and exhibit meticulous attention to detail in all aspects of your work. Qualifications - External Your qualifications should include: * Bachelor's Degree, relevant experience may substitute for degree. * At least two years of experience related to the conduct of oncology clinical trials. * Working knowledge of clinical trials, Federal, State, and Local Regulations, and IRB requirements. City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here. To learn more about our Comprehensive Benefits, please CLICK HERE.

is 100% remote, but the preference is to have someone on the east coast* The Principal Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing May perform quality control of data entry Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Provide leadership for cross-functional and organization-wide initiatives, where applicable Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications: Minimum Required: Bachelors and/or a combination of related experience Other Required: 10+ years for a Principal Clinical Data Manager Oncology experience Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Professional use of the English language; both written and oral Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong representational skills, ability to communicate effectively orally and in writing Strong leadership and interpersonal skills Ability to undertake occasional travel Preferred: Experience in a clinical, scientific or healthcare discipline Dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $133,000 - $180,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Who We Are Celebrating 40+ years! Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials. What You'll Do Remote-US Preference will be given to candidates located in the tri-state area (commutable to Princeton, NJ) As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference. Opportunity Clinical Data Manager/Sr Clinical Data Manager - dependent upon experience You will play a pivotal role in ensuring the integrity and quality of our clinical trial data. You will collaborate closely with cross-functional teams and manage data management activities for multiple studies. The primary responsibilities of this position include, but are not limited to, the following: Perform all clinical data management activities in compliance with SOPs and ICH-GCP regulatory requirements Work closely and collaboratively with the SAS Programming team, biostatistics team and other data managers Act as lead clinical data manager on multiple studies of moderate complexity with minimal supervision Serves as the main point of contact for study DM related matters Lead DM Study Start-Up Activities Conduct EDC User Acceptance Testing and program validations. Develop programs in SAS/EXCEL for study data metrics monitoring and clinical data review. Perform comprehensive data review of all patient data. Perform WHO Drug Dictionary coding and MedDRA coding as necessary Support Project Team through: Tracking and provision of project status updates to project managers for monthly project team meetings Close communication with CRA's to identify and mitigate negative data trends/issues Provision of listings/reports as needed Create ad-hoc reports for special data requests from Sponsor Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File. Coordinate all activities in preparation for study milestones and database lock May assist in the mentoring of less experienced employees Manage and prioritize project deliverables per established study timelines What You Need Level of Education and Prior Experience Bachelor's degree required / Master's degree preferred 3-5 Years relevant data management experience in the CRO / pharmaceutical industry required EDC experience required, RAVE EDC experience preferred SQL/SAS programming experience preferred Skills and Competencies Demonstrates knowledge of GCPs and protocol Strong understanding of CDISC CDASH and SDTM Standards Highly effective ability to anticipate problems relating to projects and to develop and implement solutions Excellent interpersonal skills Fluent knowledge of written and verbal English Highly organized and result-oriented Strong communication, comprehension and logic skills Ability to work independently with minimal supervision as well as in a team environment Proficient in Word and Excel Ability to understand high level programming languages Strong time management and prioritization skills to meet deadlines among multiple projects What We Offer At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $80,000-$145,000 with bonus potential. We will assess the specific title and level of entry during the interview and assessment process since the actual salary offer will be based on a number of factors, including but not limited to the candidate's qualifications, experience, skills, and competencies for the role. This position is not eligible for relocation or company provided sponsorship. Theradex is an Equal Opportunity Employer.

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions. You will make an impact: As a Senior Clinical Data Manager (Sr. CDM) you will independently act as a study lead and are responsible for the oversight, maintenance, and management of clinical trial database(s) for assigned projects through the full data management process life cycle. You are viewed as the CDM expert and will serve as the primary liaison between eClinical personnel and Sponsor personnel. You will create and oversee the database design specifications, validation, maintenance/data cleaning, and closeout activities of project-specific clinical trial databases. As a Senior Clinical Data Manager, you may delegate tasks/responsibilities to multiple team members in multiple projects. You will provide ongoing project oversight to ensure proper planning and timely completion of high-quality Sponsor deliverables. Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. Your day to day: Primary representative for eClinical Solutions and sponsor data management interaction Responsible for monitoring and ensuring adherence to study timelines and deliverables Accountable for the overall quality of data management activities and deliverables at the study or program level Ensure efficiency and consistency for data management tasks across programs Communicate with global study teams Participate in client study kickoff and closeout/lessons learned meetings Create materials for and present at Investigator Meetings Develop content and deliver Sponsor CRA and/or site training Delegate tasks, support and provide guidance to study data management team Oversee and/or develop data management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help Text Oversee and/or Develop Internal System Testing (IST) plan for database/user roles/edit check specifications Participate in Internal System Testing (IST) on the database/user roles/edit check specifications Assist with preparation for implementation of a centralized data management platform for strategic data cleaning and reporting Utilization of centralized data management platform including graphical patient profiles and operational analytics Compile the sponsor UAT package Oversee and/or perform data review as documented in the Data Management Plan and Data Validation Specifications Oversee and/or perform manual review/QC checks as listed in the Data Validation Specifications exception listings and reporting tools Oversee and/or perform data review for overall consistency and accuracy Oversee and/or perform vendor data reconciliation (e.g., IVRS, laboratory data) with the clinical database Oversee and/or perform query processing/resolution Provide ongoing data management reports and metrics Oversee and/or develop specifications and collaborate with programming for programming and QC of manual listings, external data reconciliation, metrics and custom reports as needed throughout the study Define and develop specifications for database, programming and/or edit check changes as needed throughout the study Track data management issues and ensure follow up to resolution Identify data issues and/or data trends, communicate to the Clinical Data Management team and Sponsor, assist with development and implementation of action plan Maintain data management study documentation Perform steps pertaining to database freeze/lock and coordinate all related activities Ongoing evaluation of process and participate in process improvement Assist in the creation and review of SOPs, WIs, and training materials Mentor junior level staff and peers on all associated tasks within a study Participate in proposal defenses Perform other duties as requested by management Take the first step towards your dream career. Here is what we are looking for in this role. Qualifications: Bachelor's degree in Pharmaceutical/Biotechnology or higher in health-related field preferred 8+ years in Clinical Data Management experience preferred Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology Strong project management experience and project team leadership skills including work planning and work delegation Experience with EDC and performing data management activities Excellent verbal and written communication skills Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel Experience with EDC and Clinical Data Management Systems Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: ****************************************************** eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need. Pay Range US Pay Ranges $100,000-$125,000 USD

Equal Employment Opportunity UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities. Minimum Qualifications: · Certified Registered Health Information Administrator (RHIA), Technician (RHIT), or an associate degree in a healthcare-related discipline with Certified Coding Specialist (CCS) certification, and a minimum of 3 years of medical coding experience. Or · Registered nurse (or medical school graduate) with a minimum of 3 years inpatient clinical experience, advanced clinical expertise and an extensive knowledge of complex disease processes with broad clinical experience in an inpatient setting. Licenses, Registrations, or Certifications Required: RN current license or RHIA/RHIT/CCS (medical school graduates are exempt from this MQ) And Must acquire CCDS or CDIP certification within 3 years of hire Preferred Qualifications: For nurse candidates, one year of CDI experience is highly desirable. Bachelor of Science in Nursing (BSN). CCDS or CDIP Certification. Job Summary: Scope\: Responsible for the overall improvement of the quality and accuracy of medical record documentation through interaction with physicians, members of the patient care team, and hospital coding staff. Function\: Ensures clinical documentation accurately reflects the appropriate level of service provided, severity of illness, and risk of mortality of each patient. Successfully facilitates the accurate representation of patient status that translates into coded data. Job Duties: Concurrently review inpatient admissions to identify opportunities to clarify missing or incomplete documentation. Collaborate with providers, case managers, coders, and other healthcare team members to facilitate comprehensive health record documentation that reflects clinical treatment, decisions, diagnoses, and interventions. Understand the general flow of health information from medical record documentation and discharge, through coding, to billing, and finally to data reporting. Utilize the hospital's designated clinical documentation system to conduct reviews of the health record and identify opportunities for clarification. Apply knowledge of inpatient ICD-10 coding guidelines and clinical documentation requirements to assign working MS-DRG. Enter review information and working MS-DRG/APR-DRG's with associated length of stay in the shared information system, and update this information as needed to reflect any changes in the patient's status, procedures, and treatments. Communicate with providers either through discussion or in writing (e.g., formal queries) regarding missing, unclear, or conflicting health record documentation for clarification. Conduct follow-up of posted queries to ensure queries have been answered and physician responses have been appropriately documented. Educate and communicate clinical documentation opportunities in the appropriate hospital venues for staff and physician learning opportunities. Act as a consultant to coding professionals when additional information or documentation is needed to assign coded data. Collaborate with HIM/coding professionals to review individual problematic cases and ensure the accuracy of final coded data in conjunction with CDI managers, coding managers, and/or physician advisors. Assume responsibility for professional development by participating in workshops, conferences and/ or in-services. Keep current with changes in coding guidelines, compliance, reimbursement, and other relevant regulatory updates. Contribute to a positive working environment and perform other duties as assigned or directed to enhance the overall efforts of the organization. Maintain positive and open communication with physicians, members of the patient care team, case management, and hospital coding staff. Adhere to internal controls and reporting structure. Comply with all relevant policies, procedures, guidelines, and other regulatory, compliance, and accreditation standards. Performs related duties as required Knowledge/Skills/Abilities: Demonstrate excellent observation skills, analytical thinking, and problem-solving, plus good verbal and written communication. Salary Range: Actual salary commensurate with experience. Work Schedule: Remote work, Texas resident, Monday through Friday, 8 am to 5 pm, and as needed on occasion.

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary The Manager, Clinical Vendor Management is a member of the Clinical Trial Excellence Vendor Strategy & Management team and is responsible for facilitating the identification, selection, and management of clinical study vendors and providing portfolio level issue trending, escalation and management. This role will act as a liaison between Apogee and external vendors while working to find cost savings and operational efficiencies and will help support and implement the strategic vision outlined by the Vendor Strategy & Management Lead. He/she will work with cross-functional members of the Apogee organization (Clinical, Finance, and Legal) to assess the best fit for Apogee's growing Phase 2 and 3 trial needs. This role will focus on initial MSA contract negotiations, rate cards, scope review and issue escalation associated with assigned vendors. This individual will participate in the standardization of Clinical Operation processes and will ensure sourcing objectives are aligned with corporate/operational goals. Key Responsibilities Collaborate with business partners to research and evaluate potential vendors based on their capabilities, pricing, and service level agreements Build strong relationships with key vendors Conduct ongoing assessment of vendor relationship performance through KPI review, vendor performance trend analysis, and administration/interpretation of stakeholder satisfaction surveys Drive and improve existing systems and processes Maintain knowledge of market trends for assigned key vendors Lead and conduct high visibility and competitive negotiations Support sourcing policies, contingency plans, and additional strategic initiatives established by the Vendor Strategy & Management Lead Support Clinical Operations Vendor Sourcing and vendor governance related meetings Hold vendors accountable to performance goals/agreements Drive annual third-party vendor spend savings while improving processes and vendor relationships Closely manage deliverable timelines and cross-functional input to keep reviews, decisions, and initiatives on track Participate in the continuous improvement process for programs within purview Lead/participate in vendor strategy and budget discussions Collaborate on contracts review to verify compliance with MSA, discount structures, and performance requirements Ideal Candidate Knowledge of the drug development process in complex indications for large global programs Strong understanding of contracting process and ability to negotiate and manage contractual arrangements. Ability to prepare bids, requests for quotes, and proposals Excellent communication skills with an ability to present to a variety of stakeholders and tailor messages accordingly Proven ability to influence and make decisions in a matrixed environment Comfortable leading candid conversations on vendor delivery and driving to resolution of performance challenges Partnering with study teams and vendors to effectively manage conflicting viewpoints and challenging situations with minimal negative impact Experience in problem solving capabilities; can see a problem from multiple angles and provide viable, innovative options for resolution Demonstrated ability to effectively manage priorities to achieve goals and support unplanned work Bachelor's degree in management, finance, or related field 5 years of relevant experience working in a pharmaceutical/biotech company or CRO Excellent leadership skills and big-picture mentality Ability to keep pace with a fast-moving organization Availability to participate in calls across multiple international time zones Exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and Egoless Ability and willingness to travel up to 20% The anticipated salary range for candidates for this role will be $150,000 to $160,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits Flexible PTO Two, one-week company-wide shutdowns each year Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. A pogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here 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.

Job Summary: The Clinical Data Quality Specialist is a critical member of the Client Services team, providing support to the clinical leads, abstractors and clients by supporting various quality tasks. Essential Functions: Orient the abstraction team to the medical records Perform initial re-abstractions for new additions to the abstraction team (Greenlighting) Provide abstractor re-education as needed to drive quality outcomes and/or improved use of technology Manage and perform weekly ongoing IRR to completion and quality standards Assist with fallout reviews and/or second looks Assist with case abstraction assignment at direction of Team Leader Perform harvest submission as needed Attend client calls as required Complete assigned abstractions As a growth organization, roles and responsibilities often evolve and adapt over time. As such, this job description may not comprehensively account for future activities, responsibilities, and priorities-these may evolve right along with us! Required Skills/Abilities: 1+ years abstraction within the GWTG Stroke Registry Intermediate proficiency with MS Office. Exposure to multiple patient medical record systems (EMRs) and clinical databases. Passion for training others, providing effective and constructive feedback. Ability to thrive in an ever-changing environment. Excellent organizational skills and ability to navigate through ambiguity. Prime responsibility keeping PHI secure and confidential. Education and Experience: Bachelor's Degree or equivalent experience, preferred 1+ years of experience abstracting quality data in assigned service line Total Rewards: At Q-Centrix, our purpose-safer, consistent, quality healthcare for all-drives everything we do. To accomplish this important work, we need to attract, engage, and retain a talented team by providing a compelling, equitable rewards package comprised of an inclusive culture, flexible work environment, learning and development opportunities, competitive pay that rewards high performance, and robust benefits that support health and financial wellness. Add to this package a supportive community of people who help each other not only do meaningful work, but learn, grow, and have fun while doing so, and you get an organization that has earned the Great Place to Work distinction multiple years in a row! The target wage range for this role is $33.00 - $36.00 per hour. Individual wage rates within this range are based on multiple factors including but not limited to skills, experiences, licensure, certifications, and other business and organizational considerations. Wage ranges are reviewed, at minimum, annually and all team members are eligible for performance-based wage rate increases annually. In addition to our inclusive and innovative working environment and competitive pay, full-time* team members enjoy: A fully remote work environment with flexible schedule and a generous Paid Time Off program with additional paid time for volunteering. Robust benefits package including medical, vision, dental, health savings accounts, company paid short- and long-term disability, employee assistance program, paid parental leave, life insurance, accident insurance, and other voluntary benefit programs for employees and their eligible dependents. 401(k) retirement plan with a company match. Paid professional development hours and other supportive resources. *Team members who work 30 or more hours each week are considered full-time Commitment to Diversity, Equity, Inclusion and Belonging: At Q-Centrix, we hire people who love learning, value innovation, and believe in our purpose of safer, consistent, quality health care for all. We applaud qualified applicants who are accountable and committed to producing quality work. As an Equal Opportunity Employer, we support and value diversity, dignity, and respect in our work environment, and are committed to creating an inclusive environment in which everyone can thrive. We employ people based on the needs of the business and the job, and their individual professional qualifications. Here's what does not impact our employment decisions: race, religious creed, religion, color, sex, sexual orientation, pregnancy, parental status, genetic information, gender, gender identity, gender expression, age, national origin, ancestry, citizenship, protected veteran or disability status, health, marital, civil union or domestic partnership status, or any status or characteristic protected by the laws or regulations in locations where we operate. If you are an individual with a qualified disability and you need an accommodation during the interview process, please reach out to your recruiter. Candidate Privacy Statements

The Clinical Device Data Specialist is responsible for ensuring the quality and integrity of device data and other data collected as part of a clinical study. Responsibilities: * Understand the device data collected as part of clinical studies (pre and post market) and manage the data ensuring compliance with protocol, regulatory, GDPR and HIPAA requirements. * Conduct regular reviews of device data to ensure quality and integrity and follow issues from identification through resolution. * Support the development of clinical study databases and conduct data reviews including query generation/closure. * Support device management including ordering, shipping, returns, tracking and forecasting as needed. * Develop and/or review study-specific data management and database documentation, which may include but is not limited to: Data Management Plan (DMP), and Data Transfer Specifications (DTS) and training materials. * Prepare data for scheduled snapshots/data locks. * Ensure appropriate maintenance of study databases and device data including closure and archival upon study completion. * Attend study-specific team meetings and produce requested metrics, which may include query information or data trends. * Support set-up and management of the Device Data Portal for clinical studies. * Ensure compliance with company policies and procedures as well as applicable regulatory requirements (e.g. federal/country and local). * Performs other duties as required. Education and Experience: * Bachelor's degree and/or an equivalent combination of education or experience * Minimum of 3+ years of clinical data and/or research experience Preferred Skills and Competencies: * Able to prioritize workload, assign realistic completion dates, and complete assignments on schedule. * Able to work in a high paced, changing environment and participate with other departments to achieve company goals. * Excellent written and oral communications skills required. * Proficiency in Microsoft Word and Excel required. Experience with database software and computerized statistical software is a plus. * Working knowledge of Good Clinical Practices (GCP), ISO, FDA regulations including 21 CFR part 11, and current industry practices related to the conduct of clinical trials, developing databases and managing protected health information. * Strong organizational skills and attention to details. * Ability to work independently and manage multiple tasks in a fast-paced environment. Travel Requirements: * This position requires some travel (up to 5% of the time). NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $76,350.00 - $114,525.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: * Medical, dental, and vision insurance * 401(k) with company match * Paid time off (PTO) * And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights)

Remote Clinical Data Code, Oncology needs 2+ years of experience in clinical data coding, preferably in oncology trials. Clinical Data Code, Oncology requires: Part time 20 hours weekly Bachelors degree in Life Sciences, Health Information Management, or related field. Strong understanding of clinical trial data standards and regulatory requirements. Excellent attention to detail and ability to manage multiple coding tasks in a fast-paced environment. Results-driven, take initiative and ownership to accomplish work. Knowledge of ICH, Good Clinical Practice and FDA regulations. Proficiency with Rave Coder and familiarity with MedDRA and WHO Drug dictionaries. Effective time management and organization skills. Strong communication skills for cross-functional collaboration with CRAs, CDMs, and medical reviewers. Experience with coding in global, multi-site oncology studies. Good interpersonal, written and verbal communication skills. Clinical Data Code, Oncology duties: Perform ongoing medical and medication coding using Rave Coder in accordance with MedDRA and WHO Drug dictionaries. Review and resolve auto-coded and manually coded terms, ensuring alignment with SMPA coding conventions and internal SOPs Collaborate with Clinical Data Managers to clarify ambiguous or unclear verbatim terms and issue coding queries when necessary Maintain coding listings and ensure all terms are coded and approved prior to database lock Support coding-related documentation and contribute to the development and maintenance of coding guidelines and SOPs Participate in system validation, user acceptance testing, and updates related to coding modules and dictionary integrations. Review and resolve complex or ambiguous verbatim terms, escalating to medical reviewers or clinical teams as needed. Monitor coding metrics and quality indicators, proactively identifying trends and areas for improvement. Ensure adherence to Data Management standards

SummaryAs an MRI Clinical Applications Specialist (CAS), you will be supporting the GE imaging applications team. You will deliver clinical and operational expertise by providing excellent education and training supporting the MRI modality. As a clinical expert, you will be responsible for enhancing the customer experience by supporting our commercial teams from pre-sale through post implementation by providing effective outcome-based education and training solutions. The Clinical Applications Specialist will be supporting the following states: UT, CA GE HealthCare is a place with big impact. We unlock opportunities for our people, our customers, and their patients, turning big ideas into realities that advance global healthcare.Job Description Essential Responsibilities: Develop product, clinical, and software knowledge, skills, and competence within the MRI modality. Correlates theoretical knowledge with clinical and product information to provide clinicians with the knowledge and the skills to obtain optimal performance from their GE Healthcare equipment. Provides pre-sale product clinical evaluations and/or educational sessions to potential customers in partnership with customers, develop and administer clinical training to the end-user personnel aligned with Sales Order Agreement (SOA) to deliver excellent clinical education to achieve high Net Promotor Scores (NPS). Collaborate and coordinate the delivery of customer training with a targeted integrated account management approach including sales, project management, and other service organization teams in accordance with the SOA/terms and conditions. Drive realization of revenue thru execution of on-site or remote clinical education delivery. Produce comprehensive, consistent and timely completion of documentation requirements from pre through post training. Provide ongoing post-installation training and support as needed over the lifecycle of the product. Maintain customer relationships through proactive touches and communicate all relevant product and/or customer concerns or opportunities to the Management team, Field Sales, Marketing, Customer Loyalty Leads, and Technical Support regarding technical and clinical issue or how to improve the quality of the product or overall product offerings. Qualifications/Requirements: Associate's degree or equivalent and minimum of 3 years technical/clinical industry experience. ARRT or equivalent specific MRI modality certification. Comfortable in a clinical/patient environment. Proficient use of software applications, such as, Windows Outlook, Word, PowerPoint, and Excel and navigating other computer and web-based tools (intranet/internet/apps). Ability to learn specialized industry specific software and provide digital education and training solutions. Will be required to register with one or more vendor credentialing services by various customer hospitals. Required to travel extensively, 80+% (4-5 days per week including overnights and some weekends), within the territory via multiple modes of transportation (car, air travel, train etc.) as necessary. You will receive a company car. Desired Qualifications: Minimum 3 years of GEHC MRI experience. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support. #LI-MA4 #LI- SLC #LI-UT We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $89,600.00-$134,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No

100% Remote / Flexable work schedule The Data Specialist assists in the review of patient information and medical records. This role assists with inquiries, providing information about medical records and addressing concerns. The Data Specialist is required to complete accurate input of patient demographics information, medical histories, diagnoses, treatments, and outcomes transcribing from electronic medical records into registry software. Support coding and classification activities by gathering relevant patient data. This role reports to the Registry Manager. Competencies: Education: Requires successful completion of a) r Associate's degree from an accredited School OR b) two years of work experience Coursework of two semesters of "Human Anatomy & Physiology" preferred Knowledge: * Requires knowledge of anatomy, physiology, medical terminology * Knowledge of registry codes, data entry, and criteria for reporting cases * Microsoft Office Suite, virtual meeting applications * Knowledge of Healthcare Insurance Portability and Accountability Act (HIPAA) * Assists in case inclusion/exclusion. * Reviews, identifies and accessions reportable cases from pathology and the hospital's disease index * Abstracts data required under supervision, including information available through multiple hospital systems and from necessary external sources * Assist with maintaining patient follow-up * Review medical record documentation, abstract, and enter clinical data into registry software * Ensure timeliness, completeness, and accuracy of data entry in accordance with guidelines * Maintain ability to effectively utilize Microsoft Office and department specific software applications to perform work * Provides administrative support to registry department as directed * Data quality and review: correction of missing, incomplete, and invalid data fields * Meet agreed upon data abstraction deadlines to comply with regulatory / stakeholder requirements * Maintain compliance in protecting patient confidentiality when reviewing, communicating, and accessing clinical data * Collaborate with other members of respective registry data team to create and maintain data in a confidential manner * Performs other related duties as assigned Skills: * Must be comfortable with, but not limited to: Microsoft Office Suite, web-browsers, email, electronic health records, online collaboration software, virtual meeting applications * Must be familiar with various technologies such as, but not limited to security (e.g., Citrix), data collection/abstraction, encoders, web-based applications * Strong interpersonal skills and ability to effectively communicate with team members * Up-to-date understanding or experience with clinical registries and research * Ability to work in a dynamic, team-oriented environment * Ability to work independently and be self-directed * Ability to work under pressure to meet submission, project and reporting deadlines * Ability to work in a fast-paced academic teaching hospital Required Licensure Certification, etc.: None. * Work Experience: * Minimum of two years of related healthcare experience or data entry Salary Range: Minimum $/visit - Maximum $/visit. Compensation will be commensurate with equity and experience for roles of similar scope and responsibility. In cases where the range is displayed as a $0 amount, salary discussions will occur during candidate screening calls, before any subsequent compensation discussion is held between the candidate and any hiring authority. We are committed to creating a welcoming and inclusive environment, where we embrace and celebrate our differences, where all employees feel valued, contribute to our mission of serving the community, and engage in equitable healthcare delivery and workforce practices. Johns Hopkins Health System and its affiliates are drug-free workplace employers.

Job DescriptionSynthesis HealthWho We Are We're a mission and values driven company with tremendous dedication to our customers. Our 100% remote team, spread across the US and Canada, is dedicated to a common goal - to revolutionize healthcare through innovation, collaboration, and commitment to our core values and behaviors. About the Opportunity The Senior Clinical Applications Specialist at Synthesis Health is a key member of the implementation team and operates at the intersection of clinical workflows, customer engagement, product development, and technical operations. This individual leads and supports end-to-end customer onboarding, from pre-sales product demonstrations through implementation, training, and post-go-live support. The role requires deep expertise in imaging workflows, including DICOM, RIS/PACS, structured reporting and clinical training. This position is responsible for delivering effective and personalized training to radiologists, technologists, and administrators-both remotely and onsite-while also configuring administrative and user preferences, mapping exams, and providing high-level technical support for software and hardware environments. Key Responsibilities:50%: Training, Onboarding & Customer Engagement Conducts comprehensive training sessions-onsite and virtual-for radiologists, technologists, and administrative staff, tailored to their specific roles and workflows. Leads the creation and delivery of role-specific training content to maximize adoption, increase user proficiency and drive clinical workflow optimization. Configures and customizes administrative settings, including customer account preferences, user groups and workflow configurations to align with organizational goals. Provides hands-on support during go-live events, ensuring smooth transitions, clinical readiness, and successful user adoption. Acts as the primary point of contact for clinical users, providing prompt support and ensuring ongoing satisfaction with the system. Partners with sales and product teams during pre-sales engagements to deliver impactful product demonstrations and address workflow-specific inquiries. 20%: Data Management, Exam Mapping & Workflow Optimization Manages study compendium normalization, including regex-based exam name standardization and exam mapping across disparate systems. Oversees DICOM data integrity and structured report parsing (DSR), ensuring accurate ingestion, classification, and accessibility of imaging studies. Collaborates with internal teams to optimize data-driven workflows, facilitating seamless integration across clinical and technical systems. Assists with ongoing system assessments to enhance reporting, image routing, and interoperability between Synthesis platforms and third-party systems. 10%: Technical Support & Troubleshooting Provides advanced software and hardware support related to Synthesis clinical applications, including troubleshooting connectivity issues, DICOM configurations, and workstation setups. Partners with engineering and QA to escalate and resolve system bugs, performance concerns, and workflow blockers. Works closely with integration specialists to ensure technical implementations meet the required specifications and user expectations. 10%: Cross-functional Collaboration Collaborates with product, engineering, and implementation teams to relay customer feedback and help shape future development. Participates in testing, validation, and quality assurance processes for new features and updates. Develops internal knowledge resources, standard operating procedures, and job aids to support customer-facing teams. 5%: Process Improvement & Innovation Continuously evaluates training approaches, implementation strategies, and user feedback to identify areas for process improvement. Recommends operational enhancements to increase scalability and efficiency of application deployment and support. 5%: Other duties Other duties as assigned. Qualifications 3+ years in a healthcare setting and/or working on clinical applications. Experience with DICOM data workflows, structured reporting, and interoperability standards. Strong understanding of radiology workflows, DICOM standards, and clinical data management. Proficiency in developing regex rules and troubleshooting clinical software. Excellent verbal and written communication skills, with the ability to deliver engaging training sessions. Proven ability to manage multiple tasks and prioritize effectively in a dynamic environment. Customer-focused mindset with a proactive approach to problem-solving. Preferred Qualifications ARRT certification. 3+ years in radiology, sonography, or healthcare administration You will adhere to our company's values and behaviors and incorporate them in your interactions with colleagues and customers. Values: Clinical service first. 2. Collaborate with our customers. 3. Listen, respect, learn. 4. Innovate to excel. Behaviors: Be nice. 2. Be creative. 3. Be honest. 4. Be helpful. Compensation and Benefits Compensation is paid in the currency of the country where the individual is hired. For this position, the salary range is $90,000 - $115,000. Other benefits include but not limited to: Medical, Dental, Vision, "Use as needed" vacation policy, and participation in our employee option program. Synthesis Health is an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law.

At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them. We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra, “We create for patients” doesn't just live on our walls but drives our decision making as we build the company, creating the products, processes and culture that make it happen. This team has delivered a solid foundation of development and clinical data, enabling over $200 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials. Summary: SpyGlass Pharma is seeking a Clinical Application Specialist with a strong grasp of cataract surgery and a solid understanding of surgical protocol and OR flow. This role focuses on supporting surgeons and site staff during the assembly and delivery of SpyGlass's sustained-release drug delivery technology, which is integrated into the cataract procedure. This role also includes assisting with patient identification, and recruitment in collaboration with site teams. The ideal candidate brings experience in the operating room, the ability to guide surgical teams through precise device preparation and delivery, and clear, confident communication skills. This is a field-based role requiring regular travel to clinical trial sites and close collaboration with the Clinical Applications Manager and cross-functional teams. Please note: This is a U.S. based, remote position that requires regular travel to clinical trial sites across the country (up to 70%). Applicants must be currently authorized to work in the United States and comfortable with a travel-based schedule. Essential Duties and Responsibilities: Provide hands-on procedural support during implant cases, offering real-time coaching and troubleshooting to ensure successful use of SpyGlass's sustained-release drug delivery technology. Train and coach surgical staff-including surgeons, scrub techs, and circulating nurses-on proper assembly and delivery of the device. Ensure site teams are confident in integrating SpyGlass's technology into existing surgical workflows. Train clinic staff in explaining SpyGlass's technology and its benefits to patients. Collaborate with the Clinical Applications Manager and other team members to report procedural feedback and contribute to training improvements. Maintain compliance with FDA regulations, GCP guidelines, and SpyGlass Pharma's internal SOPs. Represent SpyGlass in a professional manner during site visits, meetings, and industry events as needed. Qualifications Required for Position: Bachelor's degree in life sciences, nursing, healthcare, or a related field preferred. 5+ years of experience in clinical, surgical support, or ophthalmic medical device roles, ideally with cataract surgery. Comfortable providing support and guidance in operating room settings. Demonstrated ability to instruct clinical and surgical staff on device setup and procedural workflow. Strong observational skills and attention to detail during surgical procedures. Clear and professional verbal and written communication skills. Familiarity with clinical research environments and regulatory compliance (e.g., FDA, GCP). Ability to travel up to 70% to support trial sites across the U.S. Proficiency in Microsoft Office and clinical documentation systems. Why SpyGlass Pharma? We are offering a range of $90,000 - $110,000, based on experience and qualifications, along with an Annual Bonus opportunity. Share in our success with stock options, giving you a stake in the company's future. Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options. Generous paid time off, including holidays, vacation days, and personal leave. SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to *********************** and let us know the nature of your request and your contact information.

At Talkspace, we are committed to fostering a diverse, equitable, inclusive, and belonging-centered workplace where everyone can thrive while making a difference in mental health. Want to help over one million people receive quality mental healthcare? Come join our mission of getting therapy in the hands of everyone! Please review our open roles to see if there is a position that suits your skills and interests. If none of our current openings are a fit, indicate your interest here by submitting a resume and answering a few questions about yourself. Our team will continue to monitor incoming profiles and will reach out when we have an opportunity that could be of interest to you! Perks Of Being A Talkspacer Comprehensive medical, dental and vision plans for individual and dependent(s) with coverage effective day one 401k retirement savings program with matching up to 4% Voluntary benefits such as disability, basic life or pet insurance, etc. Wellness stipend along with discounts on gym memberships and other wellbeing products Maintain a healthy work/life balance with parental leave, flexible PTO, and company-paid holidays Regular team events, including [virtual] Happy Hours and Game Nights Generous Referral Bonus programs, especially for Technology roles Free access to all Talkspace and Lasting products For more information on online therapy and to stay updated on the latest Talkspace news, check out these resources: Talkspace Research - ********************************** Talkspace Blog - ******************************* Talkspace Tips and Resources for Parents - b2b.talkspace.com/webinar-back-to-school-august-2022-view Follow & Friend us: Talkspace Instagram - ****************************************** Talkspace LinkedIn - ******************************************************************** Talkspace Twitter - ***************************** Why Talkspace? Talkspace is a clinical quality led telebehavioral healthcare company, focused on making quality behavioral health accessible and affordable to millions in need. Its signature psychotherapy and psychiatry product connects individual users with a network of thousands of licensed mental health providers through an easy-to-use and HIPAA-compliant web and mobile platform. With Talkspace, users can send their dedicated providers unlimited text, video, picture and audio messages from anywhere, at any time. Talkspace also provides psychiatry services and prescription fulfillment, adolescent therapy and couples counseling. Our focus to help people feel better starts at Talkspace, where we connect and collaborate as a team to make the world a better place. Do you want to save the world? Come join us! EQUAL OPPORTUNITY EMPLOYER Talkspace welcomes and celebrates talent from all backgrounds, perspectives, and walks of life to foster an innovative and diverse workforce. We encourage you to apply, even if you don't meet every qualification, if you believe you could make a great addition to this team. Come as you are and learn about the exciting opportunities on our team. Individuals seeking employment at Talkspace are considered without regard to race, color, religious creed, sex, national origin, citizenship status, age, physical or mental disability, sexual orientation, marital, parental, veteran or military status, unfavorable military discharge, or any other status protected by applicable federal, state or local law.

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Purpose of the position Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking Responsible for collecting, tracking and supports reporting of research related Transfer of Value (TOV) to enable compliance with Transparency reporting requirements (US and EU) Responsible for ensuring study documentation (including trial master files, study related contracts and financial level documentation) and study documentation is processed, maintained/archived in compliance with ICH-GCP, Company policy and procedures. Includes liaison with service providers in regard to the e-TMF process and resolving issues related to missing documentation Performing QC checks on TMFs to ensure completeness and readiness for audit/inspection Contributes to clinical trial excellence initiatives Main responsibilities and tasks: Be responsible for setting-up, monitoring verifying and archiving the clinical Trial Master File (TMF) In charge of the electronic TMF (and/or paper TMF, if applicable) set-up and administration. Manage the clinical study creation and set-up for the country and site binders and the trial milestones. Prepare and customize the TMF Oversight plan, TMF Management plan, TMF master index & business rules, according to the clinical study specificities with the CRM/CPM and the Document Owners. Inform the appropriate role of all study team members (CRO) newcomers or departure. Ensure the TMF is being maintained up-to-date and all essential documents are appropriately filed in the TMF. Perform continuous oversight of the CRO TMF activities, in checking the documents consistency and the respect of the SOP timelines to maintain the TMF data integrity and by communicating this oversight status to all relevant the study team members. Coordinate the TMF Quality Check (per client SOP) with the CRO to ensure the eTMF inspection readiness. Coordinate the final TMF reconciliation with the CRM/CPM. In charge of archiving the TMF Be responsible for follow- up and review of financial documents, in collaboration with CRM/CPM Create and update financial information within the financial K2 system (Internal Order, Purchase Order, goods receipt & invoices), if not managed by a dedicated position within the team Create and follow-up of the clinical study Commitment Requests within the dedicated tool (K2) Create and update the specific clinical study budget trackers Review invoices against CRO/Vendor contracts and study progress to provide recommendation of approval or not to the CRM/CPM Follow up of the clinical study invoices to secure payments in time. Support, if necessary, the CRM/CPM in the clinical study budget such as forecast preparation, attendance to quarterly review meetings. Responsible for tracking, collecting and disclosure of expenses in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US) Collect all the information related to reportable transfers of value (ToV) to Healthcare Professionals (HCPs) & Healthcare Organizations (HCOs) in the Group Transparency system (Collect) Ensure the complete data tracking by the CROs with the Data Collection Template (DCT), organize presentation of the instructions to the CROs if needed. Check the data received from the CROs with the support of the CRM/CPM Ensure the information is properly recorded in the COLLECT system, implement corrective actions where needed Ensure the Transfers of value collected (directly or via the CROs) in COLLECT are validated along the way in compliance with the disclosure timings requirements. When needed, create new HCP/HCO records in the COLLECT system Where applicable, check the disclosure consent of Healthcare Professionals (HCPs) for each activity When needed, liaise with the Local Transparency Manager (LTM) or the Global Transparency Manager (GTM) to ensure the mandatory information for HCPs & HCOs is tracked in the Transparency system Responsible for data entry and status updates within the Clinical Trial Management System (CTMS) When assigned on a study, get access to the study record in eCTMS Check the eCTMS study data using the Clinical Operations Reporting (i.e. Clinical Operations Dashboard, CSS Monthly Report) and update as applicable (at study/region/site level: status, study sites creation, study team/contacts, recruitment, study milestones tracking) with the support of CRM/CPM for the monthly report purposes Ensure the study team contacts and handovers are properly tracked in eCTMS Provide the excel tracker to the CRO together with instructions to get all the necessary information monthly to feed the eCTMs Update the eCTMS with the CRO tracker information after validation with the CRM/CPM as per the CTMS user guide (at study, region and site level as applicable) Coordinate and conduct in-house and external clinical operations activities Generate contract templates within the dedicated system (i-CAP), follow-up until the clinical study contracts are signed and secure proper filing and archiving of all fully executed contracts Collect and follow-up of all legal administrative documents such as Power of Attorney (POA), Letter of Authorization (LOA), Confidentiality Disclosure Agreement (CDA), Kbis… Ensure insurance certificate and renewals are being requested prior to the study start-up and during the course of the study Coordinate the dispatch order for the clinical supplies if not managed by a dedicated system such as IVRS, meaning the collection of appropriate documents permitting to obtain import license and release study drugs Set-up and maintain shared study electronic site (SharePoint, box or other tools) Organize appropriate logistics for any Sponsor meetings (invitation/room booking/lunch order...) such as Investigator's meeting, DRM & TFLs, Steering Committee, … Attend all study team meeting when appropriate and take meeting minutes Perform any clinical study activity delegated by CRM/CPM such as the project management and monitoring of clinical studies, including liaison with monitors, CROs, drug vendors, central laboratories and other vendors Other missions to the position Be active member of dedicated working groups to achieve clinical operation excellence and harmonization by updating/revamping processes Coordinate the writing of articles related to the clinical study or working groups to be posted in the monthly newsletter Provide support to the medical writer within the Clinical Study Report (CSR) to secure the collection of appropriate appendices such as investigators' Curriculum Vitae, list of Ethics Committee & List of participating investigators EHS responsibilities: Comply with applicable EHS regulations and procedures. Participate in the site's EHS performance by reporting risks, malfunctions or improvements Participate in mandatory EHS training Experience / Qualifications Experience: Ideal: experience in clinical study environment within CRO or Pharmaceutical company. Minimum: Knowledge of the clinical study environment with a strong theorical or practical administrative organization. Scientific background is an asset. Qualification: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. Bachelor's degree preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 3 years). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Language: English: Strong intermediate level Key Required Technical Competencies Ability to work in a strong regulated environment within a quality management system (QMS) Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader …) Ability to organize and prioritize Able to produce work in teams and within a multi-disciplinary environment Basic Financial Knowledge- must be able to work with financial tracking tools Knowledge of Pharmaceutical Industry R&D Good knowledge of the Good Clinical Practices (GCP) or other clinical study regulations Compensation and Benefits The hourly pay range estimated for this position based in North Carolina is -. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

Job DescriptionDescription: Company: Visionix USA Travel: 100% of the time About the Role We are seeking a highly skilled and experienced Clinical Application Specialist (CAS) to join our team. This is a remote role with frequent travel across the United States. The ideal candidate is a certified ophthalmic technician or clinical educator with strong presentation skills, a deep understanding of ophthalmic technology, and a passion for customer education and support. As a Clinical Application Specialist, you will be responsible for delivering a best-in-class installation and training experience to customers across the U.S. This includes hands-on setup, clinical education, and ongoing support for Visionix and Optovue product lines. Requirements: Key responsibilities include Unpack, Install, configure, and train customers on a variety of diagnostic devices, including: Visionix systems (VX650, VX130+, VX120DE, VX110, VX65, EyeRefract) Optovue OCT systems (iVue80, iScan80, iFusion80, Solix) Nexy, WAM-5500, and additional systems as the portfolio grows Deliver product training to physicians and staff to ensure proper usage and optimal patient outcomes Perform data transfers and system networking (in collaboration with customer IT teams) Troubleshoot installation or setup issues and escalate as needed to service or R&D teams Support the sales team with the installation and clinical issues. Manage and book all travel arrangements in accordance with company policy Complete and submit training documentation in a timely manner (within one week) Provide outstanding customer service and act as a clinical resource post-installation Support trade shows, international client training, and clinical research data collection Assist with the tracking of installation and training paperwork to keep outstanding compliance with regulatory. Assist in the development of training materials (written and video) Represent the Clinical Applications department in product development and internal meetings Maintain professionalism and a clean, organized installation area Stay adaptable with evolving product lines and new technologies Extensive travel will be required. (Including some weekends) Assist in other projects or duties, as requested Qualifications A.S. degree or equivalent experience required 10+ years of clinical experience in optometry or ophthalmology 5+ years as a Clinical Application Specialist preferred JCAHPO COT or COMT certification required Advanced knowledge of OCT, refractive technologies, and eye anatomy/physiology Strong presentation and training skills across varying education levels Technical proficiency in Microsoft Windows and networking Must be able to lift 50 lbs and travel frequently Valid US driver's license, reliable transportation, and the ability to use personal credit cards for reimbursed travel expenses Fluent in English (written and spoken) Why Join Visionix USA? Be part of a cutting-edge global company in the eye care tech space Work with innovative products that make a difference in patient care Collaborate with a dynamic and supportive team Gain exposure to leading clinicians, universities, and industry events Benefits Competitive salary and full benefits package 401(k) Retirement Plan Medical, dental, vision, life, and disability insurance Paid Time Off (PTO) Equal Opportunity Employer We are an Equal Employment Opportunity and Affirmative Action Employer. We are committed to creating an inclusive environment for all qualified applicants and employees. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, marital status, veteran status, or disability.