Description : Clinical Trials Associate (FSP). Company : null. Location :

Poland, Remote Additional Locations: Bucharest, Bucureşti, Romania; Sofia, Bulgaria; Warsaw, Poland Job ID R0000014150

Category Clinical Trials

ABOUT THIS ROLE

AtParexel FSP, you will be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

We are looking for aClinical Trail Associate100% home based in Europe.

Your tasks will be

• Establishes and maintains the Trial Master File (eTMF) in inspection-ready state
• Establishes and maintains the Clinical Trial Management System (CTMS)
• Assists study team by performing administrative tasks as needed
• May assist with the creation and maintenance of documents and plans for assigned clinical studies,

including but not limited to training materials, study binders, plans, presentations, and reports

• Assists in activities associated with company-sponsored site quality audits as well as regulatory

authority inspections

• Works under general supervision in performing regular job duties and receives general instructions on

new assignments

• Assists in vendor oversight and vendor contact management
• Performs all duties and responsibilities in accordance with the Code of Federal Regulations (CFR),

Good Clinical Practice/International Council of Harmonization (GCP/ICH) Guidelines, Standard

Operation Procedures (SOPs), and other applicable guidelines

From you we expect:

• Bachelor of Science/Arts (BS/BA) or equivalent preferred, or relevant and qualifying training/experience
• A minimum of 1-year clinical operations experience within the pharmaceutical or biotechnology industry (global experience required)
• Basic knowledge and understanding of Essential Documents, CFR and/or GCP/ICH
• Proficiency with technological systems (Microsoft Office-Excel, PowerPoint, SharePoint Online, eTMF and CTMS (Veeva Vault Clinical required), EDC (Electronic Data Capture), Zoom, OneNote.
• Fundamental understanding of filing systems and organizational tools

• Proficiency in written and spoken English • Proficient in local language, as applicable

Other Requirements:

• This position may involve travel to Client for training or study needs, as applicable.

Join a global community where you can transform your career into a life-changing achievement.

Apply directly or contact us via email at [email protected]

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