Empresa: Kenvue
Descrição da vaga: Kenvue is currently recruiting for:Scientist II, Clinical OperationsThis position is based at São José dos Campos, Brazil.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. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of 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.What will you doThe Scientist II, Clinical Operations is responsible for clinical Operations activities, acting as Study Manager and/or Study Monitor for regional and/or global projects for Consumer Health products that may include Baby, Face, Body, Women’s Health, Oral Care, Sun Care or Self-care in support of product development and claims substantiation.Clinical Operations activities include (but are not limited to) clinical study management under GCP compliance, development, planning, startup, conduct, and closure of clinical studies as well as site/CRO qualification and management.Key Responsibilities
- Operate 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, in cooperation with Healthcare Compliance, Quality & Compliance, Information Security Risk Management, and Contracting teams.
- Serve as the primary point of contact with selected ESPs globally 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 study-specific essential documents including informed consent forms (ICFs), training materials, source documents, case report forms (CRFs), statistical analysis plans, recruiting materials, etc. As needed, coordinate the translation of study-specific documents and the procurement of appropriate license agreements.
- 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 through review/preparation of monitoring plans/reports, ongoing communication with the ESPs, review of clinical listings and logs, and routing/resolution of queries.
- Identifies and raises 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.
- Track invoices against key deliverables and review/approve invoices from vendors to ensure timely payment and compliance with contracts and study budgets.
- Contribute to the writing and review of Clinical Study Reports, ensuring they are written and approved within required timelines.
‘,’!*!
Kenvue is currently recruiting for:Scientist II, Clinical OperationsThis position is based at São José dos Campos, Brazil.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. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of 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.What will you doThe Scientist II, Clinical Operations is responsible for clinical Operations activities, acting as Study Manager and/or Study Monitor for regional and/or global projects for Consumer Health products that may include Baby, Face, Body, Women’s Health, Oral Care, Sun Care or Self-care in support of product development and claims substantiation.Clinical Operations activities include (but are not limited to) clinical study management under GCP compliance, development, planning, startup, conduct, and closure of clinical studies as well as site/CRO qualification and management.Key Responsibilities
- Operate 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, in cooperation with Healthcare Compliance, Quality & Compliance, Information Security Risk Management, and Contracting teams.
- Serve as the primary point of contact with selected ESPs globally 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 study-specific essential documents including informed consent forms (ICFs), training materials, source documents, case report forms (CRFs), statistical analysis plans, recruiting materials, etc. As needed, coordinate the translation of study-specific documents and the procurement of appropriate license agreements.
- 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 through review/preparation of monitoring plans/reports, ongoing communication with the ESPs, review of clinical listings and logs, and routing/resolution of queries.
- Identifies and raises 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.
- Track invoices against key deliverables and review/approve invoices from vendors to ensure timely payment and compliance with contracts and study budgets.
- Contribute to the writing and review of Clinical Study Reports, ensuring they are written and approved within required timelines.
‘,’!*!
What we are looking forRequired Qualifications
- Minimum of a bachelor’s degree in Science, Pharmacy, Chemistry, Biomedical Science, Engineering or related fields.
- Minimum 1 year of experience as an independent Clinical Study Manager (or equivalent role) including, but not limited to, experience with protocol development, informed consent form, other essential clinical documents and electronic trial master file (TMF) management.
- Advanced English is required (spoken and written).
- Flexible attitude and ability to work with global study teams and ESPs in an agile environment.
- Excellent attention to detail. Efficient, organized, and capable of prioritizing multiple tasks.
- Proficiency in Microsoft applications including Outlook, Word, Excel, Teams, PowerPoint, and Adobe.
- Good interpersonal relationship skills and being able to work effectively in cross-functional teams both internally and externally to the organization.
- Willingness to adapt to changing priorities and assignments.
- Willingness to travel up to 10% of time.
‘,’!*!
What we are looking forRequired Qualifications
- Minimum of a bachelor’s degree in Science, Pharmacy, Chemistry, Biomedical Science, Engineering or related fields.
- Minimum 1 year of experience as an independent Clinical Study Manager (or equivalent role) including, but not limited to, experience with protocol development, informed consent form, other essential clinical documents and electronic trial master file (TMF) management.
- Advanced English is required (spoken and written).
- Flexible attitude and ability to work with global study teams and ESPs in an agile environment.
- Excellent attention to detail. Efficient, organized, and capable of prioritizing multiple tasks.
- Proficiency in Microsoft applications including Outlook, Word, Excel, Teams, PowerPoint, and Adobe.
- Good interpersonal relationship skills and being able to work effectively in cross-functional teams both internally and externally to the organization.
- Willingness to adapt to changing priorities and assignments.
- Willingness to travel up to 10% of time.
‘,’Latin America-Brazil-São Paulo-São José dos Campos’,’Latin America-Brazil-São Paulo-São José dos Campos’,”,”,”,”,”,”,’R&D’,’R&D
Localização: São José dos Campos – SP
Candidate-se ao emprego agora!