Ref #: 33558

Employment type: Permanent - Full-Time

Location: Bulgaria

Posted: 05-Nov-2021


We are hiring a Clinical Trial Assistant in Serbia to work closely with our client, a leading pharmaceutical company.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.