Senior Clinical Study Administrator - Warsaw (Office based) - FSP
Primary Location: Poland, Remote Job ID R0000047643 Category Clinical Trials
About this Role
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. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.
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. You will manage essential study documentation, tracking systems, regulatory and site start-up activities, and meeting preparation, helping ensure that every study remains inspection-ready, compliant with ICH-GCP, and focused on high-quality outcomes.
You will join a collaborative, growth-oriented environment where your contributions are highly visible and where continuous learning, professional development, and meaningful impact are part of everyday work. Your organizational skills and attention to detail will help teams deliver studies on time, within budget, and to the quality standards that sponsors and regulators expect.
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), and support others in using these systems, except where a dedicated role manages system set-up and updates.
- 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, including study team meetings, monitor meetings, and investigator 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 to support effective delivery of a study and its documents.
- Hold operational responsibility for the correct set-up and maintenance of the local electronic Trial Master File (eTMF) and Investigator Site File (ISF), including document tracking in accordance with ICH-GCP and local requirements.
- 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, complete the local part of the eTMF, and support the CRA with ISF close-out activities.
- Contribute to the production and maintenance of study documents, ensuring template and version compliance.
- Take responsibility for layout and language control, copying, and distribution of documents, and support local translation and English spell checks as required.
- Print and distribute documents such as letters and meeting minutes, and handle and archive study and country-related emails.
- Interface with Data Management Centre and/or Data Management and Global Clinical Solutions representatives to facilitate the delivery of study-related documents and materials.
- 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, where appropriate, regulatory authorities for the duration of the study.
- Create and/or import clinical-regulatory documents into the global electronic management system (such as ANGEL), ensuring compliance with the client's Authoring Guide for Regulatory Documents.
- Contribute to electronic applications and submissions by handling clinical-regulatory documents to Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.
- Prepare and/or support site-level contract preparation, except where a dedicated role prepares site contracts.
- Prepare, support, or perform Health Care Organization (HCO) and Health Care Professional (HCP) payments in accordance with local regulations.
- Ensure compliance with the client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
- Ensure compliance with local, national, and regional legislation, as applicable.
- Complete the required training curriculum.
- Complete timesheets accurately as required and submit expense reports as required.
- Update your CV as required.
- 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, with the ability to respond quickly to shifting demands and opportunities
- 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 (or an equivalent adapted to local market needs) that support the skills and capabilities of the position and ensure successful conduct of responsibilities and appropriate interactions with internal and external customers
Preferred Qualifications
- Working knowledge of the clinical study process and an understanding of the range of working procedures relating to it
- 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.
- People who motivate and face challenges together.
- Innovative technology.
- Excellent training.
The potential base pay range for this role is PLN 100,000 to 130,000.
The actual salary offered may vary within this range based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.
Some roles may also be eligible for additional incentives, bonuses, or other compensation programs.
Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.
We offer a comprehensive benefits package to eligible employees, which includes paid time off, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.
If this job does not sound like the next step in your career, but perhaps you know someone who would be a perfect fit, send them the link to apply.
We believe in flexibility, growth, and creating space for people to do their best work.
Join us and be part of a team where your contributions help shape the future of clinical research.
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