Senior Clinical Trial Associate

This is a fully remote position, open to applicants in Poland, +2 more countries.

📋 Description

• Provide logistical assistance to one or more global study management teams throughout all stages of clinical study management: Start-up, Conduct, and Close-out

• Build and sustain relationships with members of the study management team, affiliate teams, and vendors

• Aid the Clinical Trial Manager by facilitating communication between the study management team and affiliates

• Coordinate global supplies utilizing designated systems in partnership with the Clinical Trial Manager

• Organize study-related meetings and prepare presentation materials

• Compile study information for trackers and databases

• Assist in protocol feasibility, country, and site selection processes

• Support technical and logistical processes associated with the study

• Monitor and maintain study documentation and information, reporting on study progress

• Keep records of study management data, team contacts, country contacts, and distribution lists

• Track submissions and approvals from Health Authorities, IRBs, and IECs in CTMS; identify delays and escalate issues as necessary

• Provide submission and supplementary documentation to affiliates or Product Development Regulatory

• Ensure the completeness of the study-level Trial Master File in compliance with SOP requirements

• Contribute to the establishment of best practices and process enhancements, incorporating insights from study debriefs

⛳️ Requirements

• Minimum of 3 years of experience as a project specialist at a global level in clinical trials

• Proficient in computer skills, including CTMS, EDMS, and MS-Office applications such as Excel and Word

• Knowledge of and adherence to relevant ICH-GCP Guidelines, international and local regulations, Parexel procedures, and Client-specific procedures

• Strong oral and written communication abilities

• Capability to prioritize multiple tasks and meet project timelines

• High dedication to consistently producing high-quality work

• Effective problem-solving capabilities

• Ability to mentor and train less experienced staff when appropriate

• Active engagement as a process and/or platform Subject Matter Expert (SME) with minimal LM oversight

• Fluent in English and Polish, both oral and written

• Relevant qualifications or equivalent experience required

• High school diploma; a degree in life sciences or a related field is preferred

🏝️ Benefits

• Competitive salary

• Attractive benefits package

• Comprehensive medical care plan: Health, Dental & Vision

• Life Assurance coverage

• Excellent working environment

• Culture of teamwork and collaboration

• Supportive team that motivates and tackles challenges together

• Access to innovative technology

• Outstanding training opportunities

• Annual performance-based bonus plan (for eligible roles)

• Annual salary review (for eligible roles)

• Total rewards incentives (for eligible roles)