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.

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

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

• Organize global study supplies utilizing designated systems.

• Schedule and manage study-related meetings while preparing presentation materials.

• Compile study information for trackers and databases.

• Assist in protocol feasibility assessments, as well as the selection processes for countries and sites.

• Support both technical and logistical aspects of study processes.

• Monitor and document study information and progress, providing regular reports.

• Maintain study management data, including team contact information, country contacts, and distribution lists.

• Track submissions and approvals from Health Authorities, IRBs, and IECs in CTMS, identifying delays and escalating issues as necessary.

• Provide submission and additional documentation to affiliates or Product Development Regulatory teams.

• Ensure the completeness of the study-level Trial Master File under the direction of the CTM.

• Identify opportunities to enhance processes and contribute to best practices.

• Apply insights and recommendations from study debriefs and best practices.

⛳️ Requirements

• A minimum of 3 years of experience as a project specialist at a global level in clinical trials.

• Proficient in computer skills, including CTMS, EDMS, Excel, and Word.

• Familiarity with and adherence to ICH-GCP Guidelines, international and local regulations, Parexel procedures, and client-specific protocols.

• Strong oral and written communication abilities.

• Capability to prioritize multiple tasks and meet project deadlines.

• Effective problem-solving skills.

• Ability to mentor and train less experienced staff when appropriate.

• Active involvement as a Subject Matter Expert (SME) in processes and/or platforms with minimal oversight from line management.

• Proficient in both English and Polish, with strong oral and written skills.

• Relevant qualifications or equivalent experience are required.

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

🏝️ Benefits

• Competitive salary.

• Attractive benefits package.

• Comprehensive medical care plan including Health, Dental & Vision coverage.

• Life Assurance.

• Exceptional work environment.

• A culture that fosters teamwork and collaboration.

• Access to innovative technology.

• Outstanding training opportunities.

• Annual performance-based bonus plan for eligible positions.

• Annual salary review for qualifying roles.

• Total rewards incentives for eligible positions.