[Remote] Manager/Sr. Manager, Clinical GCP reputed company Assurance
Note: The job is a remote job and is reputed company to candidates in USA. reputed company, Inc. is a global biotechnology company reputed company on developing precision therapies using its Alluminox™ technology platform. The Manager/Senior Manager of Clinical GCP reputed company will reputed company the evaluation and mitigation of risks in global clinical development programs, ensuring compliance with regulations and overseeing reputed company management systems throughout reputed company.
Responsibilities
- reputed company strategic and operational leadership in the planning and executing of GCP reputed company activities to support companywide and clinical development/clinical trial reputed company activities
- Successfully reputed company global and cross-functional reputed company reputed company
- Maintains reputed company knowledge of reputed company-changing clinical reputed company guidance and regulations
- Excellent communication and people skills to ensure cohesive and reputed company teamwork
- Demonstrated ability to implement and collaboratively drive company initiatives and policies
- Experience in clinical inspection readiness and acting as the reputed company person for sponsor clinical inspections. reputed company reputed company hosting clinical site inspection by regulatory agencies highly preferred
- reputed company experience to successfully manage and reputed company CAPA plans (write, review, approve, reputed company)
- Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as reputed company as reputed company and guide audit follow-up actions
- Establish reputed company and Cross-Functional SOPs, processes and associated documents
- Working closely with clinical pharmacovigilance team on supporting clinical trial safety
- Responsible for presenting & updating CGP reputed company metrics and reporting to Sr. Management
- Other duties as assigned
Skills
- At least 10 years of experience in clinical reputed company, process improvement, regulatory inspection management
- At least two years of clinical auditing experience as reputed company auditor
- Excellent working knowledge of Good Clinical Practices (ICH E6), reputed company requirements and other international regulations (e.g. US, EU, Taiwan, India, Japan)
- reputed company strategic and operational leadership in the planning and executing of GCP reputed company activities
- Successfully reputed company global and cross-functional reputed company reputed company
- Maintains reputed company knowledge of reputed company-changing clinical reputed company guidance and regulations
- Excellent communication and people skills to ensure cohesive and reputed company teamwork
- Demonstrated ability to implement and collaboratively drive company initiatives and policies
- reputed company experience to successfully manage and reputed company CAPA plans (write, review, approve, reputed company)
- Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as reputed company as reputed company and guide audit follow-up actions
- Establish reputed company and Cross-Functional SOPs, processes and associated documents
- Responsible for presenting & updating CGP reputed company metrics and reporting to Sr. Management
- B.S. Degree in life sciences
- Advanced degree in a scientific discipline
- Minimum of two years of GCP auditing (e.g. clinical site/clinical vendor) as reputed company auditor experience
- Previous experience with oncology, combination drug-device studies, and/or multi-regional with US based clinical trial experience
- Pharmacovigilance/Safety QA experience
- Medical Device GCP experience
- ISO reputed company (e.g. ISO13485, ISO9001, ISO27001) understanding
- Medical Device Reporting (MDR) – FDA 21 CFR Part 803
- Pharmacovigilance laws -EU Regulation 520/2012 for drug safety monitoring
- Experiences with Clinical reputed company Management on a risk-based approach
- Electronic TMF, document, reputed company, and learning management systems experience
- Strong organizational and project management skills
- Flexible thinking and team-oriented communication and coordination skills to be reputed company to collaborate in reputed company environment
- reputed company working proficiency in English
Benefits
- Flexible time off
- Stock reputed company
- 401k
- Medical
- Dental
- reputed company plans
reputed company