Job Description
As a Clinical Operations Lead you are part of the Global Clinical Operations community.
Responsibilities
In this role, you are responsible for various critical tasks that are part of the successful delivery of clinical trials in Belgium.
This might include the tasks below (non-exhaustive list):
- Leading the local study team:
- Establishing and meeting country-level commitment regarding study timelines, patient recruitment, budget
- Provide direction and leadership to the local study team, including the CRAs
- Ensure adequate tracking of the relevant information into the dedicated tools and systems
- To manage and oversee that all operational aspects of studies from feasibility to study close down are performed (in close collaboration with the local study team and other colleagues):
- Conducting Protocol and Site Feasibility
- Performing / Supporting IRB/IEC submission and contract negotiation
- Develop risk assessment and quality plans
- Ensures the effective and efficient delivery of country aspects in accordance with the study development plan and ICH/GCP standards, Client SOPs, local SOPs and local regulatory requirements
- Ensuring timely and adequate payment of project variable costs
- Development of relationships with Investigators
- Represent Belgium in the global study team
- Partner with other colleagues (global and locally) to ensure best practices, issue escalation and consistency
- Ensure compliance with fair market value and local compensation standards within the country
- Be part of a local community of experts for certain processes such as clinical trial submission, site payments,...
Requirements
- You are an experienced clinical research professional
- You are fluent in Dutch, French and English
- You are passionate about delivering innovative clinical trials and bringing better trials to more patients
- You believe in customer-centricity, actively aiming at understanding patient and site needs
- You actively contribute to a culture of helpfulness, putting people first
- You have the ability to influence, motivate and bring people together to encourage growth and innovation
- You thrive in a diverse and inclusive work environment
- You are an effective communicator that shares information transparently and strategically. You are an active listener
- You apply your organizing and problem-solving skills to plan and run efficient operations and enabling aspects of Clinical Operation's programs, studies, and/or enabling projectsYou thrive leading or being an active member of large or small diverse teams
Benefits
- Full-time position
- 2 days per week on site
- Contract with Oxford Global Resources
Vacancy number : 24871
