Clinical Study Administrator - FSP

Key Accountabilities:

Trial and Site Administration

• Assists in coordination and administration of clinical studies from the start-up to execution and closeout. 

• Serves as local administrative main contact and works closely with the CRAs and/or the Local Study Associate Director (LSAD) for the duration of the study. 

• Sets-up, populates and accurately maintains information in Client tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc.) and supports others in the usage of these systems (except for countries where there is a specific role dedicated to set up and update the systems). 

• Manages and contributes to coordination and tracking of study materials and equipment.  

• Coordinates administrative tasks during the study process, audits, and regulatory inspections, according to company policies and SOPs. 

• Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. o Liaises with internal and external participants and/or vendors, in line with international and local codes. 

• Prepares, contributes to, and distributes presentation material for meetings, newsletters, and websites.  

Document Management

• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents. 

• Operational responsibility for the correct set-up and maintenance of the local electronic Trial Master File (eTMF) and Investigator Site File (ISF) including document tracking in accordance with ICH-GCP and local requirements. 

• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”. 

• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF. 

• Contributes to the production and maintenance of study documents, ensuring template and version compliance. 

• Responsible for layout and language control, copying and distribution of documents. Supports with local translation and spell checks in English to/from local language, as required. 

• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related emails. 

• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material.  

Regulatory and Site Start Up Responsibilities

• Collects, assists in preparation, reviews, and tracks documents for the application process. 

• Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study. 

• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ANGEL) ensuring compliance with the Client’s Authoring Guide for Regulatory Documents. 

• Contributes to electronic applications/submissions by handling clinical regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.  

Budgeting, Agreements and Payments

• Prepares and/or supports contract preparation at a site level (except for countries where there is a specific role dedicated to preparing site contracts). 

• Prepares/supports/performs Health Care Organizations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.  

Skills (Essential):

• Proven organizational and administrative skills. 

• Computer proficiency. 

• Proficient in written and spoken English language required. 

Skills (Desirable):

• Ability to develop advanced computer skills to increase efficiency in daily tasks. 

• 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. 

• Excellent 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.  

Knowledge and Experience (Essential):

• Previous administrative experience preferably in the medical/ life science field. 

Knowledge and Experience (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.  

Education:

• High school/Secondary school qualifications (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensuressuccessful conduct of responsibilities and appropriate interactions with internal and or external customers. 

• Further studies in administration and/or in the life science field are desirable.