Assists in the coordination and administration of the study activities from start-up to execution and closeout
Serves as local administrative main contact, working closely with CRAs and trial managers
Sets up, populates, and maintains information in Client tracking and communication tools
Manages and tracks study materials and equipment
Coordinates administrative tasks during the study process, audits, and regulatory inspections
Leads arrangements and contributes to meeting preparation
Interfaces with Investigators, external service providers, and CRAs during document collection
Operational responsibility for local electronic Trial Master File and Investigator Site File
Ensures essential documents are uploaded timely to maintain the eTMF
Collects, prepares, reviews, and tracks documents for application processes
Prepares and/or supports contract preparation at a site level
Performs Health Care Organizations payments in accordance with local regulations

Degree (or equivalent) supporting skills and capabilities of the position
Proven organisational and administrative skills
IT proficiency
Proficient in written and spoken English and fluent in French
Previous administrative experience preferably in the medical/life sciences
Good working knowledge of the Clinical Study Process and ICH-GCP guidelines
Good verbal and written communication
Good interpersonal skills and ability to work in an international team environment
Willingness and ability to train others on study administration procedures
Excellent organization and time management skills and attention to detail
Ability to multi-task in a high-volume environment with shifting priorities
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
Integrity and high ethical standards

Senior Clinical Study Administrator

Key skills