Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.Job Description - ASSOCIATE MANAGER, CLINICAL OPERATIONS (2407021177W)Who We AreAt Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID that you already know and love. Science is our passion; care is our talent.What will you doThe Associate Manager, Clinical Operations is responsible for coordinating the study management operational aspects for higher complexity clinical studies for regional and/or global projects for Consumer Health products that may include Baby, Face, Body, Sun Care and Self Care in support of product development and claims substantiation.Key ResponsibilitiesLead all operational aspects of assigned clinical studies in accordance with ICH GCP guidelines, company standard operating procedures, and local regulations.Ensure that all clinical trials are conducted in compliance with the study protocol and all contractual agreements to ensure subject safety, data quality and accurate study timelines, budgets and quality standards are met.Participate in and coordinate the selection/evaluation/setup of external service providers (ESPs) (e.g., study sites, investigators, etc.) including execution of quality/security assessments, confidentiality agreements, healthcare compliance submissions, clinical trial agreements, and purchase orders.Serve as the primary point of contact with selected ESPs and train site personnel on study-specific protocol procedures and overall general Kenvue requirements.Collaborate under the direction of Clinical Operations Study Management Leads globally who will provide study operational delivery strategy and guide on critical study elements.Prepare and/or review/approve study-specific essential documents including informed consent forms (ICFs), training materials, source documents, case report forms (CRFs), statistical analysis plans, recruiting materials, etc.Oversee preparation and clinical release of investigational and auxiliary products, including determining required quantities, approving clinical label copies, overseeing development of reference safety materials, and ensuring accountability and final disposition of the products.Ensure Sponsor oversight by monitoring the progress of studies and the performance of ESPs on a continual basis.Identify and raise study-related issues and deviations to study team and senior management.Ensure that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs), and Pregnancies are reported within required reporting timelines and documented/processed appropriately.Set-up and maintain the Trial Master File (TMF) in real time following internal procedures.Coordinate and lead clinical trial disclosures on public registries, as needed.Track invoices against key deliverables and review/approve invoices from vendors to ensure timely payment and compliance with contracts and study budgets.Write and review Clinical Study Reports, ensuring they are written and approved within required timelines.Provide administrative and technical support to the junior Study Managers.Provide administrative support for site activation activities.Aid the development of the critical path for site activation within assigned projects in support of rapid site activations.What we are looking forRequired QualificationsMinimum of a bachelor's degree in Science, Nursing, or related field.Minimum 5 years of experience as an independent Clinical Study Manager (or equivalent role).In-depth knowledge of electronic trial master file (TMF) management and clinical trial management system (CTMS).Demonstrated working knowledge of cosmetic and drug regulations globally.Advanced English is required (spoken and written).Excellent written and verbal communication and presentation skills, in English.Flexible attitude and ability to work with global study teams in an agile environment.Excellent attention to detail.Good problem-solving and critical thinking skills.Efficient, organized, and capable of prioritizing multiple tasks.Proficiency in ICH GCP regulations/guidelines.Proficiency in Microsoft applications including Outlook, Word, Excel, Teams, PowerPoint, and Adobe.Good interpersonal relationship skills.Willingness to adapt to changing priorities and assignments.Desired QualificationsCCRP or equivalent certification.Experience as a Clinical Study Manager in global drug clinical studies.Primary LocationKenvue is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment 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.
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