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Principal Start Up Associate

Employer
ICON Strategic Solutions
Location
Poland
Salary
Competitive
Start date
23 Sep 2022
Closing date
30 Sep 2022

Job Details

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.

Responsibilities

Services Overview: Senior Start Up Associate is responsible for coordinating the operational and strategic aspects of clinical trial submissions applicable for countries in scope of the EU CTR for internally managed, and/or outsourced, trials, including compound level coordination. They co-ordinate the EU CTR operational clinical trial submission strategy - and develops, drives and monitors timelines/milestones. They work with central teams and country teams to ensure all information and documentation for submission to the EMA Clinical Trial Information System (CTIS) are completed and performed on a timely and compliant basis.Responsibilities include planning a compound and trial level EU CTR combined operational submissions strategy with relevant cross-functional involvement throughout the entire trial lifecycle. This role will be responsible for driving the discussions, consolidate input from all stakeholders and facilitate discussions via scenario planning with a view to agree the final EU CTR submission strategy. In addition, this role will be responsible for coordinating submissions in the CTIS portal.This position interfaces with stakeholders internal and external to Global Operations functions, such as the CTIS Administrator, GCO Country Local Submission Coordinator (local point-of-contact), Clinical Trial Manager (CTM), Global development Trial Leader (GTL), Global Regulatory Clinical Trial Application Submissions Manager (Global CTA SM), CRO point of contact, and other relevant functional area stakeholders as needed. They collaborate closely with the GTL, CTM (if applicable), LPOC and CTA SM, and are a member of the Trial Team.Major Duties/Responsibilities operations• Lead the EU Submission strategy development, planning and delivery as a member of the Cross Functional Trial Team (CFTT)• Clinical trial planning, submissions and notifications• Financial planning and tracking• Cross functional submission management• Ensure compliance with global Health Authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
Qualifications

Education and Experience Requirements/Qualifications• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).• Required: Global clinical research regulation knowledge and understanding, strong project planning/management expertise and effective communication skills.• Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.• Proven track record in successfully managing multinational clinical trial submissions to Health Authorities and or/ Ethics Committees. 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 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 through the form below.

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.

Company info
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