Clinical Operations Assistant

Parexel International; Warszawa; Hybrid; PLN 75,000 - 95,000; Full time

Benefits offered by this job

Performance bonus plan

Job summary

Parexel International in Poland is seeking a Clinical Operations Assistant to support clinical trial teams with site activation, TMF management, and progress tracking. You will assist in startup, maintenance, and closeout activities to ensure trial quality and compliance.

The role requires strong organization, English fluency, and familiarity with CTMS/EDMS in an international setting. A base pay range is provided with potential bonus eligibility.

Qualifications

• Proficient with CTMS and EDMS; Microsoft Office suite proficiency preferred.
• Excellent data management and organizational capabilities.
• Fluent English with strong local language skills for Poland.
• Experience in an international office environment is beneficial.

Responsibilities

• Support site activation, training coordination, and material shipments.
• Manage TMF documents, update lists, and resolve quality issues.
• Assist with site maintenance and data entry to ensure readiness.
• Update CTMS and trackers; flag potential issues early.
• Coordinate equipment returns and database lock activities.
• Maintain knowledge of ICH-GCP and Parexel procedures.

Skills

CTMS

EDMS

MS Office

Excel

Fluent English

Local language

Organizational skills

Communication skills

Problem solving

Education

Bachelor's degree in Life Sciences

Tools

CTMS

EDMS

Job description

About the Role

Are you organized, detail-oriented, and passionate about supporting clinical excellence? Parexel is seeking a Clinical Operations Assistant (COA) to join our dynamic Clinical Operations team in Poland.

In this pivotal role, will complete administrative tasks on behalf of assigned Project Clinical Team member which might include site management tasks during the different phases of a clinical trial as startup, maintenance and termination, contributing to the efficiency, accuracy, and quality of the trials.

Key Responsibilities

• Site Activation – Assisting site staff through vendor system access, coordinate training, and manage material shipments
• Trial Master File (TMF) Management – Upload documents on time, update Expected Document Lists, and resolve Quality Issues proactively
• Site Maintenance – Follow up on pending documents, trainings, and data entry; ensure inspection readiness
• Progress Tracking – Update CTMS and study trackers with site information; identify and escalation potential issues
• Project Closeout – Coordinate equipment returns and database lock activities with clinical teams
• Compliance – Maintain knowledge of ICH-GCP Guidelines, local regulations, and Parexel procedures.

What We're Looking For

Essential Skills:

• Strong computer skills; Proficiency in Clinical Trial Management Systems (CTMS) and Electronic Document Management Systems (EDMS) would be advantage.
• Advanced MS-Office skills (Excel, Word) – you're comfortable with data and spreadsheets
• Fluent English (oral and written), plus local language proficiency
• Exceptional organizational abilities with the capacity to juggle multiple priorities without dropping the ball
• Strong written and oral communication skills – you can explain complex processes clearly to internal and external stakeholders
• Problem-solving mindset with the ability to think creatively under pressure

Ideal Background:

• Bachelor's degree in Life Sciences or a related field (or equivalent professional experience)
• Experience in office management within an international environment
• Familiarity with clinical trial operations or healthcare administration
• Knowledge of regulatory requirements in clinical research

Why Join Parexel?

At Parexel, you'll work on cutting-edge clinical trials that transform patient lives. You'll be part of a global organization that values precision, integrity, and innovation. We invest in our people, offering opportunities for professional growth, continuous learning, and career advancement. If you're someone who takes pride in accuracy, thrives in a fast-paced environment, and wants to make a real impact in clinical research, we want to hear from you.

Base Pay Range for Poland: PLN 75,000 to 95,000.
Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.
In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and total rewards incentives.
Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles.