Ref #: 28198

Employment type: Permanent - Full-Time

Location: Poland

Posted: 03-Apr-2021

Description

Overview:
CTA performs administrative tasks to support the clinical study operation teams (Clinical Trial Managers and Clinical Research Associates) for assigned clinical trials in accordance with the company’s policies and procedures, SOP’s, local legislation and GCP requirements.

Key Responsibilities:
• Oversight of all clinical trial documentation for assigned clinical trials
• Support affiliates in HA and EC submissions
• Oversight and management of the documents filed into the eTMF: technical quality review and quality control of documents. Timely eTMF handling and archiving.
• Timely updates of relevant trial logs in the system.
• Quality check of trial documentation in the systems.
• Ensure timely and adequate archiving at closeouts.
• Providing Investigator Trial Master Files (ITMFs) core input and additional patient material during a course of study.
• Document distribution to clinical sites.
• Updating data in CTMS .
• Support clinical supplies management and tracking all relevant processes.
• Other administrative tasks (incl. payments, management of mailing lists, generic mailboxes, support in organisation of local meetings and department meetings).


Required experience and qualifications:
• Preferably Master/Bachelor degree in life sciences
• Fluent English – written and spoken
• Excellent organization and long-term planning skills
• Ability to work independently in a structured and pro-active manner as well as part of the different trial teams
• Ability to manage multiple priorities
• Very good communication skills - ability to communicate and build relationships with various stakeholders
• IT proficiency (including MS Office: Outlook, Excel, Word, PowerPoint)
• Knowledge of eTMF systems, such as Veeva Vault is considered as an advantage

How to apply?
This is an exceptional opportunity within a global organisation who offers rewarding careers. If you want to be a part of this exciting opportunity who offers a competitive salary, excellent benefits package, please contact Dariusz Sternlicht, Recruitment Consultant at DOCS and email your up-to-date CV to: dariusz.sternlicht@docsglobal.com

Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.

It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.

At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.

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