As a System Administrator at Kyndryl, solve complex problems across platforms and services for major clients. Engage in system management and security compliance while collaborating with a talented team.
About the role
- Senior Clinical Study Administrator coordinating clinical studies for leading biotechs at Parexel. Involves administration, document management, and regulatory compliance in a hybrid role.
Responsibilities
- Assists in the coordination and administration of clinical studies from start-up to execution and closeout
- Serves as local administrative main contact and works closely with CRAs and/or trial managers
- Sets-up, populates, and accurately maintains information in Client tracking tools
- Manages coordination and tracking of study materials and equipment
- Coordinates administrative tasks during the study process, audits, and regulatory inspections
- Leads practical arrangements and contributes to the preparation of meetings
- Liaises with internal and external participants and/or vendors
- Interfaces with Investigators and external service providers during document collection
- Ensures correct set-up and maintenance of the local electronic Trial Master File
- Responsible for layout, language control, copying, and distribution of documents
- Collects, assists in preparation, reviews, and tracks documents for application processes
Requirements
- High school/Secondary school qualifications
- Proven organisational and administrative skills
- IT proficiency
- Fluent in written and spoken English
- Previous administrative experience preferably in the medical/life science field
- Preferably good working knowledge of the Clinical Study Process
- Understanding of ICH-GCP guidelines
- Good verbal and written communication
- Good interpersonal skills
- Willingness and ability to train others on study administration procedures
- Excellent organization and time management skills
- Ability to multi-task in a high-volume environment
- Team oriented and flexible
- Integrity and high ethical standards
Benefits
- Open and friendly work environment
- Opportunities to develop long-term careers
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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