Clinical Study Coordinator
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 HeadTypical Accountabilities- Assists in coordination and administration of clinical studies from the start-up to execution and closeout.• Collects, assists in preparation, reviews and tracks documents for the application process.
- 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 AstraZeneca 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 AstraZeneca 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.• Leadsthe practical arrangements and contributesto 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 websites.• 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 AstraZeneca’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 applicablePeople ManagementResponsibilityDirect reports: Indirect reports: Approximate number of people managed in total (all levels): 0 0 0Individual contributor (specialist) XMatrix Manager (projects/dotted line)Manager of a team Grandfather (manager of a manager)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) X2 or 3 countriesGlobalEducation, Qualifications, Skills and Experience Essential
- High school/Secondary school qualifications (*), thatsupports 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 EnglishDesirableFurther 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.Date Posted20-dic-2024Closing Date12-ene-2025AstraZeneca embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be.We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.SummaryLocation: Spain
- MadridType: Full time