Required Clinical study administrator (CSA)
Introduction to role:
The Clinical Study Administrator (CSA) plays a crucial role in the coordination and administration of study activities from start-up to execution and close-out. Working within the Local Study Team (LST), you will ensure the quality and consistency of interventional study deliverables, meeting time, cost, and quality objectives.
Accountabilities:
Assist in coordination and administration of clinical studies from start-up to execution and close-out.
Collect, prepare, review, and track documents for the application process. Assist in timely submission of proper application/documents to EC/IRB and, where appropriate, to Regulatory Authorities for the duration of the study.
Interface with Investigators, external service providers, and CRAs during the document collection process to support effective delivery of a study and its documents.
Serve as local administrative main contact and work closely with the CRAs and/or the LSM for the duration of the study.
Maintain operational responsibility for the correct set-up and maintenance of the local eTMF and ISF, including document tracking in accordance with ICH-GCP and local requirements.
Ensure essential documents under your responsibility are uploaded in a timely manner to maintain the eTMF Inspection Readiness.
Ensure all study documents are ready for final archiving and completion of the local part of the eTMF, supporting the CRA in close-out activities for the ISF.
Contribute to the production and maintenance of study documents, ensuring template and version compliance.
Create and/or import clinical-regulatory documents into the Global Electronic Management System (e.g., ANGEL) ensuring compliance with the Authoring Guide for Regulatory Documents.
Contribute to electronic applications/submissions by handling clinical-regulatory documents according to requested technical standards (e.g., Submission Ready Standards), supporting effective publishing and delivery to regulatory authorities.
Set-up, populate, and accurately maintain information in our tracking and communication tools (e.g., CTMS such as IMPACT, SharePoint) and support others in using these systems.
Prepare and/or support contract preparation at a site level.
Prepare/support/perform Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations. Manage and contribute to coordination and tracking of study materials and equipment.
Coordinate administrative tasks during the study process, audits, and regulatory inspections according to company policies and SOPs.
Lead practical arrangements and contribute to the preparation of internal and external meetings (e.g., study team meetings, Monitors meetings, Investigators meetings). Liaise with internal and external participants and/or vendors in line with international and local codes.
Prepare, contribute to, and distribute presentation material for meetings, newsletters, and websites.
Requirements: Essential Skills/Experience:
High school/Secondary school qualifications that support skills and capabilities of the position and ensure successful conduct of responsibilities and appropriate interactions with internal and/or external customers.
Previous administrative experience preferably in the medical/life science field.
Proven organizational and administrative skills.
Computer proficiency.
Good knowledge of spoken and written English.
Desirable Skills/Experience
Further studies in administration and/or in life science field are desirable.
Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH-GCP guidelines.
Ability to develop advanced computer skills to increase efficiency in daily tasks.
Good verbal and written communication skills.
Good interpersonal skills and ability to work in an international team environment.
This position is open to all candidates.
