Title: Clinical Specialist &ndash; Registry Operations Location: Remote USA Job Description: Position Overview The Clinical Specialist &ndash; Registry Operations role is central in supporting the execution and maintenance of the ongoing clinical registry that collects real-world data on patients undergoing Barrett&rsquo;s esophagus screening with the assay run and commercialized by Lucid Diagnostics Inc. This position is primarily responsible for managing administrative and operational aspects for registry data collection, ensuring data quality, and supporting patient follow up activities. The ideal candidate is highly detail-oriented, experienced in clinical data handling, and comfortable working cross-functionally. Additional responsibilities may include field-based activities as needed; however, travel is expected to be low ( 25%). Key Responsibilities - Manage day-to-day administrative activities related to clinical registry operations - Support accurate and timely data entry and verification within the registry databases (including but not limited to the EDC, enrollment logs, etc.) - Review data for completeness and quality; identify, track, and resolve data queries in collaboration with the Clinical Research Team - Participate in registry-related meetings - Support team training activities - Support site patient and provider engagement and support data capture efforts to ensure protocol adherence - Identify workflow gaps and opportunities for process improvement - Develop process improvement strategies - Provide input to Case Report Form (CRF) specifications and participate in user requirement testing - Conduct patient follow-up activities, including: Obtaining redacted medical records; Contacting patients and/or healthcare providers to collect missing or longitudinal data; Support the team in maintaining organized documentation for registry records and communications; Collaborate with the Clinical Research and Data Management teams to ensure compliance with study protocols and applicable regulations. - Field Clinical and Product Support when needed: Includes administration of the - EsoCheck cell collection device to clinically indicated patients; educate patients and providers on the EsoGuard indications and intended use. The Clinical Specialist is - Maintain competency in EsoCheck device administration and participate in proficiency testing, as well as training other healthcare providers in device administration. - Support Client and External Collaborator Relationships as needed: Includes collaboration with the Commercial/Sales team to foster strong relationships with clients, client office staff, and other healthcare professionals - Other duties as assigned Qualifications (Required) - RN, BSN required - Minimum 3&ndash;5 years clinical experience - Demonstrated experience with data entry and clinical data systems (e.g., EDC platforms, EMRs) - Strong attention to detail and commitment to data accuracy and integrity - Experience managing data queries and working with clinical datasets - Excellent organizational and time management skills - Strong interpersonal and communication skills, including experience interacting with patients and healthcare providers - Ability to work independently and collaboratively - Proficiency in Microsoft Office - Ability to work office-based or remote with routine computer-based work with occasional travel (<25%) for site support, training, or field-based clinical activities - Ability to direct outreach to patients and healthcare providers - Familiarity interpreting EGD and pathology reports and other medical records Qualifications (preferred) - Experience with Veeva, electronic medical record (EMR) systems, and/or laboratory information management systems (LIMS) - Prior experience supporting clinical registries or observational studies - Familiarity with HIPAA and patient privacy requirements - Experience obtaining and handling medical records for research purposes - Exposure to diagnostic testing or molecular diagnostics environments - Familiarity with diseases of the gastrointestinal tract(GERD, BE, EAC) - Familiarity with Good Clinical Practice (GCP) PAVmed and its subsidiaries are committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We are also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Role Description Join Our Team as a Trial Master File Associate (1 FTE) - (home based in EU). As part of our CDS Ophthalmology team, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals. The Trial Master File Associate (TMF Associate) is part of the TMF Delivery Business Line within Clinical Development Services (CDS) and will function operationally as a member of the Study Team with the responsibility to organize, maintain, and oversee the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, TMF Functional Lead, and PM delegation. Key Responsibilities - Notify study team that TMF is created and ready for document upload for eTMF or submission to pTMF. - Develop TMF Plan. - Provide training on study specific TMF requirements, guidelines including TMF Plan. - Perform QC2 on documents and documents reconciliation. - Provide TMF Monthly Reports to PM, Line manager, and Head of TMF Delivery. - Regularly check TMF metrics, follow up on detected issues, ensure acceptable level of metrics. - Ensure TMF processes timely implementation and execution. - Adjust study specific TMF Index/EDL in the relevant files/system as directed by the PM (Project Manager). - Ensure valid forms and templates are implemented and maintained in the assigned projects. - Check status of duplicates, documents in error, size and path length (if applicable), follow up on necessary corrections accordingly. - Coordinate Monthly and Quarterly TMF Reconciliation by creating Action Plan and submitting relevant report on the status. - Ensure TMF AoR completion and monitoring TMF transfer/shipment to the Sponsor. - Ensure delivery of fully executed TMF AoR to TMF Functional lead. - Actively follow up that the study team is submitting documentation, EDL maintenance for eTMF in cooperation with study team, following the process described in The TMF Plan and that the TMF is always submission and inspection ready. Qualifications - At least 1-5 years of experience in CRO or Pharmaceutical Industry with proven TMF Management. - Bachelor’s Degree in Health Science or Document Management or equivalent work experience is preferred. - Knowledge of GCP/ICH guidelines. - Good written and communication skills. - Good organizational and multi-tasking skills. - Good software and computer skills. Benefits - We provide a competitive compensation package. - Comprehensive benefits. - Opportunity for personal and professional growth in a rewarding environment. - Join a team that values collaboration, innovation, and making a difference in the lives of patients. Company Description Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.

Title: Sr. Study Manager, Clinical Operations Location: Princeton, NJ, USA Job Description Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our &ldquo;People first&rdquo; approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho&rsquo;s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It&rsquo;s our work, our passion, and our legacy. We invite you to join us. Hybrid Employee Value Proposition: At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an exciting opportunity to lead clinical studies and experience multiple facets of Clinical Operations in a dynamic, supportive, collaborative, and global cross-functional environment. Position Summary: Under minimal supervision, leads and manages complex global studies to support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring assigned clinical studies are delivered within timelines, budget, and quality. A critical component of the position is leading, collaborating with and driving internal cross-functional study teams and managing, contract research organization (CRO) personnel and other study vendors. Performs assigned responsibilities to ensure timely completion of departmental goals and objectives. Performance Objectives: - Assume overall responsibility for the planning and execution of one or multiple global trials by managing all aspects of trial deliverables, including development of timelines, budget, recruitment and country/site selection strategies, and provision of clinical trial materials. - Serve as main study contact for the cross functional team, CROs, vendors and study sites. - Monitor KPI and performance metrics and drive related discussions and escalations with the cross functional study teams and CROs/vendors. Escalate risks/issues and reports status to clinical operation lead. - Participate in the preparation of protocols and Case Report Forms (eCRFs), monitoring, communication, and other project plans. - Author and lead the coordination of study specific documents such as Informed Consent. - Work with CROs to develop processes and mitigation strategies for assigned studies. - Collaborate with Clinical Development and CRO on study-specific training for study team and study sites. - Responsible for the financial management of the clinical trial in conjunction with his/her supervisor and finance department, including contracts, change orders and invoices. - Efficiently establish and monitor trial milestones as well as overall day-to-day operations of clinical studies, ensuring study information and timelines are accurate in internal electronic systems, reports and on government websites (CT.gov, etc.). - Ensure the timely recruitment of trial participants with secure randomization processes, if applicable, and subsequent efficient and effective data management. - Ensure compliance with and adherence to the project plan and identify, evaluate and mitigate potential risks and issues. - Oversee systems to track projects including all study, investigator and ethical review board information, patient recruitment activity, and financial management. - Liaise with the Trials Steering Committee, Data Monitoring, and Ethics Committee as required. - Provide regular and ad hoc information, both written and verbal, to all the trial participants, internal/external teams including reports, updates, guidance, preformed commitments, etc. - If required, conduct co-monitoring visits with CROs or CRAs. - Lead site identification and selection process in collaboration with internal medical lead and CROs to ensure suitability of study sites. Verifies that all research staff and facilities have adequate qualifications and resources, and these remain adequate throughout the study. - Ensure that study sites are set up properly and each has the trial materials, investigational products, and training according to trial specific requirements and industry standards. - Verify that the investigator follows the approved protocol, training and all GCP procedures and oversees the quality of the data and safety of the patients. Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to internal management and the investigator, as applicable. - Provide proper oversight of study CROs and vendor activities by creating and managing the CRO oversight plan and related activities, such as review of various monitoring visits report and follows up on any issues or trends, managing risk/issue/decision logs, etc. - Ensure data is entered and monitored in timely manner and that safety is reported in accordance with the protocol on the CRFs. - Work with internal and external functional teams to ensure drug accountability is managed at study sites and that all used and unused trial supplies are accounted for. Ensures IP release process is followed and associated documentation is complete. - Manages sites and study closeout related activities and trial completion. - Overall responsible for the Trial Master File, including review of the TMF plan, related metrics, and ongoing quality review of the TMF. Oversee TMF related CRO and internal team activities to ensure inspection readiness of trial documentation. - Support Quality Assurance on site audits, CAPA and inspection requests. - Manage and coordinate investigator meetings and internal/external team cross functional study meetings and related agenda/minutes. - Interact and communicate with Taiho&rsquo;s partners for both planning and operational execution of day-to-day activities. - Lead selection, setup and provides oversight to various study vendors such as IRT, ePRO, ECG, Central lab, etc. - Provide support, mentorship, and training for others in Clinical Operations. - Support Clinical Operation department on various projects such as SOP development or process improvement initiatives. Education/Certification Requirements: - Bachelors&rsquo; degree in the biological sciences or equivalent is required. Knowledge, Skills, and Abilities: - 3-5 years of relevant clinical trial management and leadership experience in the pharmaceutical, biotechnology, CRO and/or healthcare industry. - Has demonstrated the use of excellent communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials. - Attention to details and well-organized. - Ability to work independently with minimal management oversight. - Solution oriented and exceptional collaboration skills. - Must possess the ability to multi-task and effectively prioritize in order to ensure clinical trial goals. - Recognize potential obstacles and work to resolve them within set timelines. - Delivers work conscientiously and precisely even when under pressure. - A team player and able to work in a dynamic, fast-paced environment with attention to high quality results. - Excellent communication skills both verbal and written. - Good proofreading skills. - Takes initiative and utilizes good judgment. - Knowledge of, and competence in, application of FDA/GCP/ICH guidelines. - The incumbent in this position may be required to perform other duties, as assigned. The pay range for this position at commencement of employment is expected to be between $166,600 to $196,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment. If hired, employee will be in an &ldquo;at-will position&rdquo; and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. #Location-Princeton,NJ #LI-Hybrid The incumbent in this position may be required to perform other duties, as assigned.

• Responsável pelo planejamento, coordenação e condução das atividades do ensaio de acordo com ICH-GCP. • Colaborar e interagir com outros membros da equipe do ensaio. • Monitorar o progresso do ensaio e realizar verificações plausíveis; implementar ações corretivas se necessário. • Garantir o cumprimento das demandas regulatórias locais de Ética/Autoridades para garantir a submissão oportuna.