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
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