Job Description

The specialist study management assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

Job Responsibilities :

• Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
• 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.
• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
• Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
• 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.
• 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.
• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ERV) ensuring compliance with the Company 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.
• Sets-up, populates and accurately maintains information in Company tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems).
• Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts).
• Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
• 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. 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 web-sites.
• 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 e-mails.
• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material.
• Ensures compliance with Company’s Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Ensures compliance with local, national and regional legislation, as applicable.
• Additional country-specific tasks might be added depending on local needs.

Education :

• Level of education that supports skills and capabilities of the position and ensures 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.

Desired 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.
• 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, and 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

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