Clinical Operations Manager
Há 5 dias
About Kenvue
Kenvue is a leading global healthcare company that develops and markets a wide range of products, including pharmaceuticals, medical devices, and consumer healthcare products.
Job Summary
We are seeking a highly skilled and experienced Clinical Operations Manager to join our team. The successful candidate will be responsible for managing a team of clinical study management staff, ensuring that projects are appropriately resourced, employees are trained, and meeting project objectives and CGC Compliance.
Key Responsibilities
- Staff Management
- Oversee staff management in accordance with organizational policies and relevant regulations.
- Ensure that staff have the necessary materials, system access, and training to carry out their job responsibilities.
- Project Management
- Contribute to the allocation of resources to clinical operations projects by assigning staff to clinical studies based on their skills and training.
- Monitor the quality of clinical work performed by staff through regular review and evaluation.
- Quality Assurance
- Identify quality risks and issues and develop appropriate corrective action plans to prevent or address deficiencies in staff performance.
- Ensure that staff meet defined workload and quality metrics by regularly reviewing and reporting findings as outlined by clinical.
Qualifications
- Education
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- Experience
- Prior clinical study management experience, including experience in a people/team management capacity (at least 2 years) or equivalent combination of education, training, and experience.
- Skills
- In-depth knowledge of applicable global clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- In-depth knowledge of electronic trial master file (TMF) management and clinical trial management system (CTMS).
- Good leadership skills.
- Computer skills, including proficiency in the use of Microsoft Word, Excel, and PowerPoint.
- Advanced English language skills (spoken and written).
- Excellent organizational and problem-solving skills.
- Effective time management skills and ability to manage competing priorities.
- Ability to establish and maintain effective working relationships with coworkers, managers, and global teams.
Desired Qualifications
- Demonstrated working knowledge of cosmetic and drug regulations.
- Experience as a Clinical Study Manager in global drug clinical studies.
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