Clinical Trial Assistant 2
- Employer
- ICON Strategic Solutions
- Location
- Bulgaria, Homeworking
- Salary
- Competitive
- Start date
- 3 Nov 2022
- Closing date
- 3 Dec 2022
View more
- Discipline
- Clinical Research, Clinical Operations, Clinical Trials Manager / Administrator
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
We are looking to recruit aClinical Trial Assistant (CTA)who will work closely with our client, a leading pharmaceutical company.
Overview:
CTA performs administrative tasks to support the clinical study operation teams (Clinical Study 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
- Previous experience in RA submissions is required.
- 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
- Very good communication skills - ability to communicate and build relationships with various stakeholders
- IT proficiency (including MS Office: Outlook, Excel, Word, PowerPoint)
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.
Company
As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.
ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.
Why choose a career with ICON Strategic Solutions?
Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.
Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.
Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.
Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.
Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.
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