Compliance Intern offering forensic analysis support for Johnson & Johnson. Engaging in audits and analytical tasks in a hybrid work environment in New Brunswick, NJ.
About the role
- GCP Compliance Manager overseeing compliance activities in clinical trials at Novartis. Managing program/trial compliance and coordination with clinical teams for GCP oversight.
Responsibilities
- Responsible for compliance oversight and control of regulated GCO activities focusing on program/trial level delivery.
- Act as single point of contact for Clinical Trial Teams for GCP Compliance.
- Provide management and day-to-day support for program/trial level quality issues, deviations and quality management.
- Coordinate and support Clinical Trial Teams for audits and inspections.
- Deliver the GCO self-assessment strategy related checks and controls.
- Support cross-functions risk assessments and monitor relevant indicators/metrics/thresholds.
Requirements
- Advanced degree in science, engineering or relevant discipline.
- 8+ years industry experience in clinical operations and trial management.
- Strong understanding of clinical research international standards and regulatory requirements from Health Authorities.
- Audits and inspections experience highly desirable.
- Organizational and analytical skills associated with an aptitude in quality management and continuous improvement.
- Critical thinking ability and risk management and risk-based knowledge and mindset.
- Strong skills to facilitate/optimize contribution of team members as individuals and members of a cohesive team.
- Ability to work effectively in a matrix cross-functional environment.
- Ability to make & communicate difficult decisions with strong written and verbal communication skills.
- Self-awareness, willingness to further develop own strengths and explore opportunities for improvement.
- Must be fluent in English.
Benefits
- Relocation is not offered for this role.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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