Role Description The Clinical Trial Manager (CTM) II is responsible for the execution of operational activities for a study or group of studies at a regional level or within a small group of countries, including tracking progress and quality at clinical sites. The CTM II will lead the monitoring team and associated deliverables, including the clinical monitoring plan, site visit reports, etc. In addition, the CTM II works to ensure clinical trial timelines are being met and communicated to the Project Leader/Global Clinical Project Manager. The CTM II will independently oversee site management and site monitoring activities. Responsibilities - Possesses detailed knowledge of the study/protocol and its associated activities and timelines, leverages operational expertise to design operational strategy for trial execution. - Provides mentoring, training, and independent oversight for in-house Clinical Research Associates (CRAs), CRAs, and site management staff on assigned projects. - Leads operational implementation of a study, including management of tasks and oversight of clinical operations activities specific to each phase of the study lifecycle in accordance with corporate and project-level Standard Operating Procedures, study plans and any client/sponsor requirements or guidelines. - Establishes and maintains strong working relationships with clients, vendors, and internal collaborators. Communicates with internal and external collaborators regarding status of tasks and updates and is responsible for communication of status of activities to internal teams. - Under the guidance of the Project Leader/Global Clinical Project Manager, serves as the client/sponsor-facing point of contact for operational activities as outlined in the study’s Communication Plan. - Leads internal and external operational study calls and meetings, participates in other calls as required. - Escalates issues or concerns regarding study activities to line management and the department leadership as needed. - Leads the development and review of key study plans such as the Manual of Procedures (MOP), Clinical Monitoring Plan (CMP), Standard Operating Procedures (SOPs), pharmacy/lab manuals, TMF plan, etc. Provides operational review of the protocol if applicable. - Leads the development and review of key templates such as master informed consent form(s) and other participant-facing documents, site training materials, annotated report for each visit type conducted for the study, monitoring visit checklists, monitoring correspondence documents, etc. - Responsible for ensuring site document currency and ethics approvals, as applicable. - Ensures study timelines and deliverables are met by CRA staff, including, but not limited to, development of the clinical monitoring plan per the Statement of Work (SOW), evaluation of the risk-based monitoring strategy, monitoring visit frequency, monitoring visit report submission/approval timelines, study data collection timelines, and the annotated reports per the project SOW and/or Emmes SOPs. - Continuously evaluates current operational practices and recommends process improvements to ensure continued compliance with regulatory requirements and industry best practices. - Develops and maintains metrics related to site assessments, feasibility and selection, site activation and close out activities. - Tracks and reports on site performance metrics and quality. Stays up to date on overall study progress at the site(s) and proactively identifies and escalates risk (e.g. recruitment rates, missing data, investigational product inventory and expiration, protocol compliance, safety reporting, regulatory issues, etc.) while providing risk mitigation strategies. - Remains informed of data system progress and data management activities; may serve in a consultative role as it relates to the study protocol and operational guidelines, report development, data collection requirements, eCRF design, etc. - Maintains frequent communication with the safety/medical monitor to ensure adequate safety reporting information is included in key study documents (e.g., protocol, informed consent form) and that safety event reporting is occurring as required. Tracks reporting and follow-up of Adverse Events, Serious Adverse Events, and Suspected/Unexpected Adverse Events. - Responsible for study-level supplies and investigational product/device accountability, including coordination with vendors as applicable. - Tracks documentation and archiving of study documents. - Conducts observational, training, and co-monitoring visits with CRAs as applicable. - Assists with bid defense preparation and conduct and in the RFP/proposal process. - May assist with DSMB/DMC coordination and management. - Other duties as assigned. Qualifications - Bachelor's or a master’s degree, preferably in a science related field. - Typically possesses at least 7-8 years of relevant clinical research experience, including time as a CRA or in a clinical operations coordinating/leadership role. - Excellent team building and interpersonal skills. - Excellent organizational and analytical skills. - Excellent verbal and written communication skills. - Excellent ability to prioritize and handle multiple tasks. - Ability to work independently, as well as in a complex team environment. - Proficient with MS Office Suite. - Excellent computer and organizational skills. - High attention to detail required. - Ability to work on varying projects and exercise critical thinking. - Self-starter who can work independently and a team player who can work cross functionally with limited oversight. - Knowledgeable in clinical research operations, including interpretation and implementation of country-specific regulations/ICH guidelines, as required. - Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment. - Knowledgeable in prioritization, problem-solving, organization, critical thinking, decision-making, time management, and planning activities. - Ability to collaborate with internal and external colleagues and work well in a team-oriented setting. Benefits - Flexible Approved Time Off. - Tuition Reimbursement. - 401k Retirement Plan. - Work From Home Anywhere in the US. - Maternal/Paternal Leave. - Casual Dress Code & Work Environment.

Role Description We are looking for a Clinical Lead to own the quality and safety layer for Fabric's Medical Intelligence Team (MIT), the team that builds the clinical content, algorithms, and LLM-driven protocols at the heart of our platform. Your job is to make sure all of it meets a rigorous, evidence-based clinical bar before it reaches a patient or a clinician. This is a hands-on individual contributor role for a licensed clinician who has done formal clinical quality work and wants to define what quality looks like for AI-driven care. You will build the validation framework, set the evidence standard, run the review cadence, and be the clinical voice that says "this is safe to ship" or "this goes back." What You'll Do - Clinical Logic Creation: Partner closely with Medical Intelligence Team staff to outline necessary questions, reference sources, first line treatments for predicted diagnoses, appropriate triage routing for particular answers, and patient education drafts. - Clinical AI Creation and Governance: Partner closely with medical intelligence, product, and engineering to develop AI algorithms and quality assurance processes that ensure the Fabric product suite is addressing medicine's Quadruple Aim. - Clinical Oversight: Provide first-pass reviews of clinical logic, safety concerns from safety audits, and other clinical decision-making documents. Present findings and recommendations with evidence-based support to the next most senior medical leader for review, edits, and implementation, as appropriate. - Technical Expertise: Become proficient in the use of LLM and other AI tools to improve both the Medical Intelligence Team's efficiency and Fabric's products at-large. - Technical Maintenance: Assist the Medical Intelligence Team with data analyses, platform implementations, and other improvements as needed. - Client Representation: Professionally represent Fabric in meetings with current and prospective clients, showcasing our expertise and commitment to innovative care. - Deliver on Deadline: Produce deliverables with specific and sometimes short deadlines, including document creation, workflow reviews, and other work relevant to the successful completion of these responsibilities. - Ad Hoc Responsibilities: Expect to be responsive to a variety of requests relevant to supporting Fabric's clinical logic products, the growth of the overall business, or the response to the unexpected. Qualifications - 5+ years as an Advanced Practice Provider (e.g., NP, PA). - Commitment to standard of care through unwavering dedication to current, accepted clinical practice guidelines and regulatory requirements. - Expert in efficient literature review (differential diagnosis, indicated diagnostics, first line treatments, patient education, and triage), supporting all decisions with evidence whenever possible. - You have applied AI agentic workflows in clinical practice or, at a minimum, are already using LLM and AI applications in your work and professional life. - Aptitude for learning new technological tools to support sound clinical decision making. - Proven ability to work well in multi-disciplinary teams outside of direct clinical care. - Detail-oriented mindset with capacity to work deep in the weeds with big picture vision in mind. - Positive, proactive, and clear communicator who collaborates well with MIT and cross-functional team members. - Excellent verbal and written communication, comfortable with both synchronous and asynchronous collaboration. - Native-speaker level of fluency in English (written and verbal). Benefits - The national pay range for this role is $140,000.00 – $160,000.00 per year. - Actual compensation will be determined by factors such as the candidate's geographic market, experience, skills, and qualifications. - Certain roles may also be eligible for additional compensation, including a comprehensive benefits package such as medical, dental, vision, unlimited PTO, and a 401(k) plan, stock options, and bonuses. This Might Not Be The Right Fit If... - You prefer direct patient care over the deep-work tasks described above; without bedside time, this role may feel isolating. - You are uncomfortable with the evolving space of AI, where guidelines and tools change weekly, or with the ambiguity of a startup environment. - You find cross-functional critique of your clinical judgement calls difficult; this role requires your clinical logic to be stress-tested by product managers and engineers. - You prefer big-picture thinking only; this role requires in-the-weeds work, manually reviewing hundreds of logic strings, auditing AI outputs, and ensuring every clinical branch is correct. - You prefer a strict clock-out mentality; while we value work-life balance, the pace of a growing health-tech company often requires ownership and responsiveness beyond a traditional shift-work mindset.

Title: Clinical Trial Coordinator - Remote, Mexico - Remote, São Paulo, Brazil - Remote, Panamá, Panama - Remote, Lima, Peru - Remote, Colombia - Santiago de Chile, Region Metropolitana de Santiago, Chile - Remote, Argentina Remote Full time What You’ll Do: • According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. • Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. • Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate. • Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system. • Provides system support (i.e. GoBalto & eTMF). • Supports RBM activities. • Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members. • Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes. • Reviews and tracks local regulatory documents. • Transmits documents to client and centralized IRB/IEC. • Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. • Maintains vendor trackers. • Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. • Assists with study-specific translation materials and translation QC upon request. • May attend Kick off meeting and take notes when required. Education and Experience Requirements: • 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 4 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. Knowledge, Skills and Abilities: • Ability to work in a team or independently as required • Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency • Strong customer focus • Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout • Excellent English language and grammar skills and proficient local language skills as needed • Good presentation skills • Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems • Ability to successfully complete PPD clinical training program • Self-motivated, positive attitude with effective strong interpersonal skills

Title: Manager R&D Self Care Innovation Location: North America, United States, New Jersey, Summit Job Description: Kenvue is currently recruiting for a: Manager R&D Self Care Innovation Who We Are Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here. Role reports to: Director, Front-End Innovation Self Care Location: North America, United States, New Jersey, Summit Work Location: Hybrid What you will do The Manager for Front-End Innovation in Self Care will be responsible for researching, interpreting, and applying the latest advances in microbiome research and related sciences, specifically within the oral and gut microbiomes and their effect on metabolism and the host immune system as well as overall systemic health. The candidate will be expected to shape an innovation strategy, different programs and pipeline of novel consumer solutions and communication platforms in relation to the oral/gut microbiomes or the effect on systemic health. This role will lead the development of Kenvue’s Microbiome Innovation Strategy for Oral and Digestive Health, as it relates to aging, overall oral/gut and systemic health and disease. The responsibilities will include establishing clinical and preclinical evaluation plans and ensuring a consumer-centric approach to communicating benefits to health care professionals (HCPs) and consumers. Success in this position requires close cross-functional partnership with Product Development, Translational Science, Medical Affairs, Regulatory, and Marketing to shape and deliver product concepts, claims, and communication strategies. External engagement will also be critical for identifying strategic partnerships, relationships with healthcare professionals, advancing future innovations in key categories, and supporting external communication of the science behind our products. The Front-End Innovation R&D Manager will additionally lead a small team of 2–3 subject matter experts, providing daily coaching, mentorship, and development support. Key Responsibilities - Conduct scientific research of existing literature in the space of overall human Microbiome and the respective effect on immune health and metabolic pathways, - Understanding the Oral-Gut-Brain-Skin axis and establishing connections and correlations of the different Microbiomes and correlation to health and aging across benefit areas - Design, execute and analyze/interpret data from clinical and preclinical studies focusing on assessing clinical safety and efficacy of self-care related technologies. Define pilots for new methodologies, define success criteria and test design. - Internal and external focus to identify best in class methodologies, claims language and consumer- and HCP- facing communications that can be leveraged across various projects. - Make recommendations for consumer centric methodologies and approach that can be applied to various types of innovation projects. - Partner with various stakeholders (i.e. R&D teams, data scientists) to identify how to leverage consumer and clinical data for claim innovation. Make recommendations on how to leverage data to accelerate decision making. - Lead a team of 2-3 scientists and guide their individual talent development What We Are Looking For Qualifications - Expertise in Biological Sciences; DMD/PhD/MD + at least 5 years industry experience; MSc level + 6-7 years industry experience - Experience and knowledge of Oral/Gut microbiome required (Pharma or Consumer); - Metabolic Health and Epigenetics knowledge/experience a plus - Ability to design, set up, conduct and analyze/interpret microbiome data - Strong scientific foundation, intellectual curiosity and critical thinking skills; knowledge of clinical biomarkers and evaluations preferred - Capable of establishing & leading scientific programs - Familiarity with Self Care regulatory requirements a plus - Able to write/present external posters and publications; interpret and present data to broad audience - Being able to connect cross-functionally to determine testing needs for a variety of projects. - Previous experience of managing a team of scientist highly preferred; able to guide and develop talent; - Up to 10% travel may be needed What’s in it for you Annual base salary for new hires in this position ranges: $141,950.00 - $200,400.00 This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors. - Competitive Benefit Package* - Paid Company Holidays, Paid Vacation, Volunteer Time & More! - Learning & Development Opportunities - Kenvuer Impact Networks - This list could vary based on location/region *Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process. Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.