Clinical Study Administrator

hace 4 semanas

Madrid, España Morgan Philips Executive Search A tiempo completo

The Clinical Study Administrator (CSA) 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.

CSAs might have different internal titles based on the experience level (CSA, Senior CSA). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head / Executive Director, Regional Head.

**Typical Accountabilities**:

- Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
- 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. ANGEL) ensuring compliance with the Authoring Guide for Regulatory Documents.
- Sets-up, populates and accurately maintains information in 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.
- 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 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.

**People Management Responsibility**:

- Direct reports: 0
- Indirect reports: 0
- Approximate number of people managed in total (all levels): 0
- Individual contributor (specialist) X
- Matrix Manager (projects/dotted line)
- Manager of a team

Span of Influence (how many countries will the role have mandate to assign work to and take decisions on)

**Operates in**:

- Own country - another country (smaller clusters) X
- 2 or 3 countries
- Global

Education, Qualifications, Skills and Experience

**Essential**:

- Experience: at least 1 year of CSA experience (trainee experience does not count in) preferably in Oncology/ Haemato-oncology trials.
- High school/Secondary school qualifications (*), 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.

**Desirable**:

- Further studies in administration and/or in life science field are desirable (*)
- Working knowledge of the Clinical Study Process

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