Empregos atuais relacionados a Scientist II, Clinical Operations Specialist - São José dos Campos, São Paulo - Kenvue Inc
-
Scientist II, Clinical Operations Specialist
2 semanas atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroScientist II, Clinical Operations SpecialistKenvue is a global leader in the development and manufacturing of everyday care products. We are currently seeking a highly skilled Scientist II, Clinical Operations Specialist to join our team.This role will be responsible for managing clinical operations activities, including study management, site qualification,...
-
Scientist II Clinical Operations
Há 1 mês
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroScientist II Clinical OperationsKenvue is a global leader in the development and manufacturing of consumer health products. We are currently seeking a highly skilled Scientist II Clinical Operations to join our team.About the RoleThe Scientist II Clinical Operations will be responsible for managing clinical operations activities, including study management,...
-
Scientist II, Clinical Operations Specialist
1 semana atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroScientist II, Clinical Operations RoleKenvue is a leading global healthcare company that is currently recruiting for a Scientist II, Clinical Operations role.This position is based in São José dos Campos, Brazil, and is part of our Consumer Health division.About KenvueKenvue is a house of iconic brands, including NEUTROGENA, AVEENO, TYLENOL, LISTERINE,...
-
Scientist II, Clinical Operations Specialist
2 meses atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroScientist II, Clinical OperationsKenvue is a leading global healthcare company that is passionate about delivering innovative solutions to improve people's lives. We are currently seeking a highly skilled Scientist II, Clinical Operations to join our team.About the RoleThe Scientist II, Clinical Operations will be responsible for managing clinical operations...
-
Scientist II Clinical Operations
Há 1 mês
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroScientist II Clinical OperationsKenvue is a global leader in the development and manufacturing of consumer health products. We are currently seeking a highly skilled Scientist II Clinical Operations to join our team in São José dos Campos, Brazil.Key Responsibilities:Manage clinical studies in accordance with ICH GCP guidelines and company standard...
-
Scientist II Clinical Operations
4 semanas atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroScientist II Clinical OperationsKenvue is a leading global healthcare company that is passionate about delivering innovative solutions to improve people's lives. We are currently seeking a highly skilled Scientist II Clinical Operations to join our team in São José dos Campos, Brazil.Key Responsibilities:Manage clinical studies in accordance with ICH GCP...
-
Scientist II, Clinical Operations Specialist
2 meses atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroAbout the RoleWe are seeking a highly skilled Scientist II, Clinical Operations Specialist to join our team at Kenvue. As a key member of our Clinical Operations department, you will be responsible for managing clinical studies and ensuring compliance with regulatory requirements.Key ResponsibilitiesManage clinical studies from start to finish, ensuring...
-
Scientist II, Clinical Operations Specialist
2 meses atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroAbout the RoleWe are seeking a highly skilled Scientist II, Clinical Operations Specialist to join our team at Kenvue. As a key member of our Clinical Operations department, you will be responsible for managing clinical studies and ensuring compliance with regulatory requirements.Key ResponsibilitiesManage clinical studies from start to finish, ensuring...
-
Scientist II Clinical Operations
Há 1 mês
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroScientist II Clinical OperationsKenvue is a leading global healthcare company that is passionate about delivering innovative solutions to improve people's lives. We are currently seeking a highly skilled Scientist II Clinical Operations to join our team in São José dos Campos, Brazil.Key Responsibilities:Manage clinical studies in accordance with ICH GCP...
-
Scientist II, Clinical Operations Specialist
2 semanas atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroAt Kenvue, we are seeking a highly skilled Scientist II, Clinical Operations Specialist to join our team.This role is responsible for clinical operations activities, acting as Study Manager and/or Study Monitor for regional and/or global projects for Consumer Health products.Clinical operations activities include clinical study management under GCP...
-
Clinical Operations Scientist II
2 meses atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroPosition Overview Kenvue is seeking a dedicated professional for the role of: Scientist II, Clinical Operations This role is integral to our operations and will be based in a dynamic environment. About Kenvue At Kenvue, we harness the remarkable potential of everyday care. With a legacy spanning over a century and a foundation in scientific innovation, we...
-
Clinical Research Scientist II
2 meses atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroPosition OverviewKenvue is seeking a qualified candidate for the role of:Scientist II, Clinical OperationsThis role is integral to our operations and focuses on managing clinical studies for our Consumer Health products.About KenvueAt Kenvue, we harness the remarkable potential of everyday care. With a legacy spanning over a century and a foundation in...
-
Senior Scientist in Clinical Operations
2 meses atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroPosition OverviewKenvue is seeking a dedicated professional for the role of:Scientist II, Clinical OperationsThis role is integral to our clinical operations team.About UsAt Kenvue, we harness the remarkable potential of everyday care. With a legacy spanning over a century and grounded in scientific expertise, we are home to renowned brands such as...
-
Senior Scientist, Systems Specialist
2 semanas atrás
São José dos Campos, São Paulo, Brasil Johnson & Johnson Consumer Inc Tempo inteiroWe are seeking a highly skilled Senior Scientist, Clinical Operations - Clinical Systems & Operational Excellence to support the global clinical operations systems and processes. This role will collaborate with key roles within the Clinical Operations organization, as well as Study Managers, Clinical IT, Bioresearch Quality and Compliance (BRQC) and related...
-
Senior Scientist, Systems
2 semanas atrás
São José dos Campos, São Paulo, Brasil Johnson & Johnson Consumer Inc Tempo inteiroKenvue is seeking a highly skilled Senior Scientist, Clinical Operations - Clinical Systems & Operational Excellence to support the global clinical operations systems and processes. This role will collaborate with key roles within the Clinical Operations organization, as well as Study Managers, Clinical IT, Bioresearch Quality and Compliance (BRQC) and...
-
Clinical Operations Manager
2 meses atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiro{"title": "Clinical Operations Manager", "content": "Job SummaryKenvue is seeking a Clinical Operations Manager to join our team. As a Clinical Operations Manager, you will be responsible for managing a team of clinical study management staff to ensure projects are appropriately resourced, employees are trained, and meeting project objectives and CGC...
-
Clinical Operations Manager
Há 1 mês
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroJob Title: Clinical Operations ManagerKenvue is a global leader in the development and manufacturing of consumer healthcare products. We are currently seeking a highly skilled Clinical Operations Manager to join our team in São José dos Campos, Brazil.Job Summary:The Clinical Operations Manager will be responsible for managing a team of clinical study...
-
Clinical Operations Manager
4 semanas atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroJob Title: Clinical Operations ManagerKenvue is a global leader in the development and manufacturing of consumer healthcare products. We are currently seeking a highly skilled Clinical Operations Manager to join our team in São José dos Campos, Brazil.Job Summary:The Clinical Operations Manager will be responsible for managing a team of clinical study...
-
Clinical Operations Manager
Há 1 mês
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroJob Title: Clinical Operations ManagerKenvue is a global leader in the development and manufacturing of consumer healthcare products. We are currently seeking a highly skilled Clinical Operations Manager to join our team in São José dos Campos, Brazil.Job Summary:The Clinical Operations Manager will be responsible for managing a team of clinical study...
-
Clinical Operations Manager
4 semanas atrás
São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiroJob Title: Clinical Operations ManagerJob Summary:Kenvue is seeking a highly skilled Clinical Operations Manager to join our team. As a Clinical Operations Manager, you will be responsible for managing a team of clinical study management staff, ensuring projects are appropriately resourced, and employees are trained to meet project objectives and CGC...
Scientist II, Clinical Operations Specialist
2 meses atrás
We are seeking a highly skilled Scientist II, Clinical Operations Specialist to join our team at Kenvue Inc. As a key member of our Clinical Operations department, you will be responsible for managing clinical studies and ensuring compliance with regulatory requirements.
Key Responsibilities- Study Management: Operate clinical studies in accordance with ICH GCP guidelines, company standard operating procedures, and local regulations.
- Compliance: 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.
- External Service Provider Management: 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.
- Training and Support: 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.
- Collaboration: Collaborate under the direction of Clinical Operations Study Management Leads globally who will provide study operational delivery strategy and guide on critical study elements.
- Document Preparation: 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.
- Product Oversight: 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.
- Sponsor Oversight: 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.
- Issue Identification: Identify and raise study-related issues and deviations to study team and senior management.
- Reporting: 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.
- TMF Management: Set-up and maintain the Trial Master File (TMF) in real time following internal procedures.
- Financial Management: Track invoices against key deliverables and review/approve invoices from vendors to ensure timely payment and compliance with contracts and study budgets.
- Reporting and Documentation: Contribute to the writing and review of Clinical Study Reports, ensuring they are written and approved within required timelines.
- Education: Minimum of a bachelor's degree in Science, Pharmacy, Chemistry, Biomedical Science, Engineering or related fields.
- Experience: 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).
- Skills: 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.
- Travel: Willingness to travel up to 10% of time.
Kenvue Inc is a leading company in the healthcare industry, dedicated to delivering innovative solutions to improve patient outcomes. We are committed to fostering a culture of excellence, diversity, and inclusion, and we are proud to be an Equal Opportunity Employer.
