Global Study Associate (ACOL) - Spain/Poland - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 Global Study Associate to join our FSP Clinical Operations department in Spain or Poland. This is an individual contributor role in which you will work alongside the Clinical Trial Manager and the wider clinical trial team.

As a Global Study Associate, you will support the Clinical Trial Manager in managing moderately complex study activities. You will help ensure GCP and SOP compliance, assist with vendor oversight and management, and take part in monitoring tasks as needed. Working closely with the clinical trial team, you will help maintain study integrity and efficiency, identifying issues in a timely manner and escalating them to management as appropriate.

This position offers the opportunity to contribute to Phase 1, 2, 3, and 4 clinical studies while building hands-on expertise across study feasibility, start-up, maintenance, and close-out. Your work will directly support the delivery of clinical research that matters to patients.

You will join a collaborative, growth-oriented environment where your contributions are visible and where continuous learning, professional development, and meaningful impact are part of everyday work.

Key Responsibilities

• Support Phase 1, 2, 3, and 4 clinical studies with guidance.
• Support activities related to study and site feasibility, start-up, maintenance, and close-out.
• Manage study and site essential document review, collection, and tracking from study start-up through maintenance and close-out.
• With guidance, support the Study Lead (such as the Clinical Trial Manager or Associate Director) in preparing and maintaining study documents and manuals, including informed consent forms, study manuals, site materials, training materials, and pharmacy and laboratory related manuals.
• Provide oversight of the Trial Master File (TMF).
• Ensure required study documents are received, reviewed, and filed in the TMF in accordance with SOPs, GCP, and applicable regulations.
• Organize study-related meetings, including preparing agendas, taking minutes, and maintaining risk, issue, and decision logs.
• Lead and present at study-related meetings as required.
• Perform applicable site monitoring and co-monitoring visits, including ad hoc, pre-study, initiation, routine monitoring, and close-out visits.
• Provide rapid action to address both internal and site quality assurance findings from audits.
• Manage, coordinate, and oversee third-party vendor activities, including deliverable metrics, accruals, process planning, and implementation.
• Perform general study tracking and maintenance, including study status, enrollment, site queries, deviations, and study-level documents and plans.
• Participate in department and clinical trial team meetings and collaborative efforts such as protocol development, CRO selection, and departmental initiatives.
• Support study site oversight, including site performance, metrics, and monitoring report review.
• Support study data activities, including data review, query creation and resolution, study and protocol deviation reviews, and safety reviews.
• Work cross-functionally and provide oversight of CRO and vendor activities, including vendor management as assigned.
• Review and verify contracted vendor activities, including vendor invoice review.
• Support study reporting and tracking using applicable systems and technology.
• Support study leads in cross-functional alignment of study timelines.
• Complete the required training curriculum.
• Complete timesheets accurately as required.
• Submit expense reports as required.
• Update your CV as required.
• Maintain a working knowledge of, and comply with, Parexel processes, ICH-GCPs, and other applicable requirements.

Candidate Profile

You'll Thrive In This Role If You Bring

• Strong verbal and written communication skills.
• A demonstrated ability to work independently and as part of a team.
• Advanced knowledge of Microsoft Word, Excel, and PowerPoint.
• The ability to prioritize and manage multiple tasks simultaneously.

Required Qualifications

• A BA or BS degree, a nursing degree, or an equivalent qualification.
• At least 3 years of experience in clinical studies as a SCRA or Lead CRA.
• Working knowledge of Good Clinical Practice (GCP) regulations and Standard Operating Procedures.
• Understanding of study phases and how they apply to clinical development.
• Working knowledge of electronic systems, including the Trial Master File and CTMS (e.g., Veeva Vault, Smartsheet, SharePoint).
• Knowledge of the principles and practices of computer applications in database management.
• 10% to 20% travel may be required.

Preferred Qualifications

• Pharmaceutical industry experience.
• Previous site monitoring or study coordinator experience.
• A science major.
• Relevant clinical trials experience.

Benefits and Compensation

Premium salary.

Attractive benefits.

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 Spain EUR 42,000 to 45,000 / Poland PLN 280,000 - 290,000.

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.