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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Clinical Study Administrator - Hybrid - Warsaw- FSP
Job ID R0000031315 , PolandParexel FSPoffers you the security of a long-term position and many opportunities for career progression.
We are currently recruiting talented and passionate people to join our FSP teams in Poland.
TheClinical Study Administratorposition flexible (3 days weekly) office based in Warsaw gives you the opportunity to join a team with a wide range of experience and expertise.
Position Purpose:
The Clinical Study Administrator (CSA) will assist in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.
Primary Duties:
- Trial and site administration and support.
- Document Management (eTMF, ISF).
- Regulatory & Site Start-Up responsibilities.
- Budgeting, Agreements and Payments.
Skills and Education:
- High school/Secondary school qualifications (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
- Further studies in administration and/or in the life science field are desirable.
- Previous administrative experience preferably in the medical/ life science field (minimum 6 months).
- TMF and ISF experience is required.
- 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.
- Proven organizational and administrative skills.
- Computer proficiency.
- Proficient in written and spoken English language required.
- Fluency in local language(s) required.
- 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.
- 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.
Join a global community where you can transform your career into a life-changing achievement.
Apply directly or contact us via email at marta.kuniewicz@parexel.com
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