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About the role
Key responsibilities & impact- Provide logistical support to one or more global study management teams through all phases of clinical study management
- Develop and maintain relationships with study management team members, affiliate teams, and vendors
- Assist the Clinical Trial Manager with communication between the study management team and affiliates
- Coordinate global study supplies using designated systems
- Coordinate and organize study-related meetings and develop presentation materials
- Consolidate study information for trackers and databases
- Support protocol feasibility, country, and site selection processes
- Support technical and logistical study processes
- Track and maintain study information and documentation and report study progress
- Maintain study management data, team contact details, country contacts, and distribution lists
- Track Health Authority, IRB, and IEC submissions and approvals in CTMS; identify delays and escalate issues
- Provide submission and supplementary documentation to affiliates or Product Development Regulatory
- Maintain completeness of the study-level Trial Master File under CTM direction
- Identify and contribute to best practices and process improvements
- Incorporate learnings and recommendations from study debriefs and best practices
Requirements
What you’ll need- At least 3 years experience as a project specialist at global level in clinical trials
- Strong computer skills, including CTMS, EDMS, Excel, and Word
- Knowledge of and compliance with ICH-GCP Guidelines, international and local regulations, Parexel procedures, and client-specific procedures
- Good oral and written communication skills
- Ability to prioritize multiple tasks and achieve project timelines
- Effective problem-solving skills
- Ability to mentor and train less experienced staff as appropriate
- Active participation as a process and/or platform Subject Matter Expert (SME) with minimal LM oversight
- Fluent English and Polish skills, oral and written
- Relevant qualification or equivalent experience required
- High school diploma; ideally a degree in life science or another related background is preferred
Benefits
Comp & perks- Premium salary
- Attractive benefits
- Medical care plan: Health, Dental & Vision
- Life Assurance
- Excellent work environment
- Culture of teamwork and collaboration
- Innovative technology
- Excellent training
- Annual performance-based bonus plan for eligible roles
- Annual salary review for eligible roles
- Total rewards incentives for eligible roles
