Kenvue is currently recruiting for:
Senior Scientist, Clinical Operations – Clinical Systems & Operational Excellence
This position is based at São José dos Campos.
Who we are
At 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 Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the 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.
Travel %: 10
What you will do
The Senior Scientist, Clinical Operations – Clinical Systems & Operational Excellence is responsible for supporting the global clinical operations systems and processes, training programs and adherence to standard processes and operating procedures (SOPs) to ensure GCP compliance and inspection readiness within Clinical Operations. The Senior Scientist, under the guidance of the Clinical Systems & Operational Excellence Manager, will collaborate with key roles within the Clinical Operations organization, as well as Study Managers, Clinical IT, Bioresearch Quality and Compliance (BRQC) and related R&D functions, leading the study management operational aspects for clinical studies for regional and/or global projects for Consumer Health products that may include Baby, Face, Body, or Sun Care in support of product development and claims substantiation.
Clinical Operations - Clinical Systems & Operational Excellence activities include (but are not limited to) an overall understanding of clinical study management workflows under GCP compliance, possess strong knowledge and/or use of clinical systems (CTMS and eTMF), and the ability to perform analysis of system-generated data to identify areas of improvement/optimization.
Key Responsibilities
A deep understanding of all operational aspects of clinical studies in accordance with ICH GCP guidelines, company standard operating procedures, and local/global regulations.
Under the strategic direction of the Clinical Systems and Operational Excellence Manager, this role will:
Support the maintenance and optimization of select Clinical Operations' systems, in accordance with ICH GCP guidelines, company standard operating procedures, and local/global regulations.
Identify system-related impact(s) on Clinical Operations processes and procedures.
Contribute to the creation and/or optimization of system-related training programs/curricula.
Serve as the Clinical Business Administrator back-up, executing delegated system administration related activities.
Support the monitoring of training assignments and adherence to global Clinical Operations policies, Quality Standards and Standard Operating Procedures to ensure inspection readiness.
Assist with identifying process challenges, impacted stakeholders and suggesting process enhancements.
Support the delivery of project plans and adherence to established timelines for system-related activities.
Identifies and raises system-related issues to the Clinical Systems and Operational Excellence Manager and/or senior management. Participates in the analysis to determine if corrective and preventative action plans are needed.
Contribute to the writing and review of Clinical Study Reports, ensuring they are written and approved within required timelines.
Assist more senior Clinical Systems & Operational Excellence team members with above and/or additional tasks as needed for higher complexity studies.
Qualifications
What we are looking for
Required Qualifications
Minimum of a bachelor's degree in science, nursing, or related field.
Experience as Clinical Study Manager (or equivalent role and/or GCP-related procedures work).
Prior experience as an end user with clinical systems including CTMS and eTMF (including partnering with IT for system maintenance and optimization).
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 (remote or geographically dispersed) study team members 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, Visio 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.
Desired Qualifications
CCRP or equivalent certification.
Demonstrated working knowledge of or experience with GCP regulatory authority inspections.
Exposure to Change Management methodologies.
What's in it for you
Competitive Total Rewards Package*
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Employee Resource Groups
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 business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.
Primary Location Latin America-Brazil-São Paulo-São José dos Campos
Job Function R&D
#J-18808-Ljbffr
