Scientist, Research & Development

我們做什麼

在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

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你會做什麼

The Scientist, Research & Development 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 For

Required Qualifications

• Minimum of a bachelor’s degree in science, Pharmacy, Chemistry, Biomedical Science, Engineering or related fields
• 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

Desired Qualifications

• Experience as a Clinical Study Manager in global Clinical Studies

What’s In It For You

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
• Learning & Development Opportunities
• Employee Resource Groups 

“The hiring company may identify potential employee moves based on succession and/or development planning. All candidates need to apply through the formal bidding process”

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