Senior Clinical Study Administrator – Warsaw

About Parexel

Parexel is a leading global clinical development partner delivering insight-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research.

About The Role

We are seeking a Clinical Study Administrator (CSA) to join our FSP Clinical Operations team in Warsaw (Poland), office based 3 days weekly. As a Clinical Study Administrator, you will play a critical role in coordinating and administering clinical studies from start-up through execution and close-out. Working within the Local Study Team, you will help ensure the quality and consistency of interventional study deliverables, meeting time, cost, and quality objectives. Acting as the local administrative main contact, you will work closely with Clinical Research Associates (CRAs) and the Local Study Associate Director (LSAD) for the duration of each study. This position offers the opportunity to contribute directly to the successful delivery of clinical research while building strong partnerships with investigators, sites, vendors, and internal study teams.

Key Responsibilities

• Assist in the coordination and administration of clinical studies from start-up through execution and closeout.
• Serve as the local administrative main contact, working closely with CRAs and the Local Study Associate Director (LSAD) for the duration of the study.
• Set up, populate, and accurately maintain information in client tracking and communication tools (such as CTMS, VCV, and SharePoint).
• Manage and contribute to the coordination and tracking of study materials and equipment.
• Coordinate administrative tasks during the study process, audits, and regulatory inspections, in accordance with company policies and SOPs.
• Lead the practical arrangements for, and contribute to the preparation of, internal and external meetings.
• Liaise with internal and external participants and vendors in line with international and local codes.
• Prepare, contribute to, and distribute presentation material for meetings, newsletters, and websites.
• Interface with investigators, external service providers, and CRAs during document collection.
• Hold operational responsibility for the correct set-up and maintenance of the local electronic Trial Master File (eTMF) and Investigator Site File (ISF).
• Ensure essential documents under your responsibility are uploaded in a timely manner to maintain eTMF inspection readiness.
• Ensure all study documents are ready for final archiving.
• Contribute to the production and maintenance of study documents, ensuring template and version compliance.
• Print and distribute documents such as letters and meeting minutes.
• Interface with Data Management Centre and/or Data Management and Global Clinical Solutions representatives.
• Collect, assist in preparing, review, and track documents for the application process.
• Assist in the timely submission of applications and documents to ethics committees (EC), institutional review boards (IRB), and regulatory authorities.
• Create and/or import clinical-regulatory documents into the global electronic management system.
• Prepare and/or support site-level contract preparation.
• Ensure compliance with the client's Code of Ethics and company policies and procedures.
• Complete the required training curriculum.
• Maintain working knowledge of, and comply with, Parexel and client processes, ICH-GCPs, and other applicable requirements.

Candidate Profile

You'll Thrive In This Role If You Bring:

• Excellent organization and time management skills.
• Excellent attention to detail.
• Good verbal and written communication skills.
• Good interpersonal skills and the ability to work effectively in an international team environment.
• A willingness and ability to train others on study administration procedures.
• The ability to multi-task in a high-volume environment with shifting priorities.
• A team-oriented and flexible approach.
• Integrity and high ethical standards.
• The ability to develop advanced computer skills to increase efficiency in daily tasks.

Required Qualifications

• Proven organizational and administrative skills.
• Computer proficiency.
• Proficient in written and spoken English.
• Fluency in local language(s).
• Previous administrative experience, preferably in the medical or life science field.
• High school or secondary school qualifications.

Preferred Qualifications

• Working knowledge of the clinical study process.
• An understanding of the ICH-GCP guidelines.
• Further studies in administration and/or in the life science field.

Benefits and Compensation

Premium salary. Attractive benefits. Car or car allowance. Medical care plan: Health, Dental & Vision. Life Assurance. Excellent work environment. Culture of teamwork and collaboration. Innovative technology. Excellent training.