Senior Clinical Study Line Manager
New
B
BeOneClinical Research
Poland RemoteFull-TimeSenior
Salary325,000 - 406,200 PLN per year
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Job Details
- Experience
- A minimum of 8 years of progressive experience in clinical research and clinical operations
- Required Skills
- Project ManagementMicrosoft OfficeMentoring
Requirements
- Bachelor’s degree or higher in a scientific or healthcare discipline.
- Minimum 8 years of progressive experience in clinical research and clinical operations.
- Experience in the biotech, pharmaceutical sector, or CRO environment.
- Proven line management experience.
- Strong knowledge of clinical trial execution and ICH/GCP guidelines.
- Familiarity with Functional Service Provider (FSP) model.
- Proficiency in Microsoft Office suite (Outlook, Word, Excel, PowerPoint, Teams).
- Strong written and verbal communication and influencing skills.
- Highly organized with effective prioritization skills.
- Skilled in risk mitigation and process improvement.
Responsibilities
- Provide leadership, management, and mentorship to Clinical Study Managers (CSMs).
- Monitor staff workload and quality metrics through regular review and reporting.
- Participate in hiring, onboarding, and training of new employees.
- Ensure clinical trial protocols are executed according to ICH/GCP and local regulations.
- Collaborate with regional teams to maintain study timelines and quality standards.
- Review study start-up templates, drug labels, and informed consent forms.
- Address site issues and identify opportunities for improvement and risk mitigation.
- Conduct regular 1:1s, performance check-ins, and performance reviews for direct reports.
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