Senior Scientist, Systems
Há 1 mês
We are seeking a highly skilled Senior Scientist, Systems to join our Clinical Operations team. As a key member of our team, you will be 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.
Key Responsibilities:- 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
- Identify and raise system-related issues to the Clinical Systems and Operational Excellence Manager and/or senior management.
- 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 patterning 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.
- 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.
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.
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