Clinical Study Manager in Fulltime

Clinical Operations
Netherlands, Rijnsweerd, De Uithof ( Utrecht)
Fulltime
V-99263
Competitive
Freelancers are also welcome to apply!As a Clinical Study Manager, you’ll be at the heart of our client’s Clinical Research team within the Specialized Nutrition unit. Your role is instrumental in overseeing the initiation and operational management of intricate clinical studies led by our Global Clinical Research team. You’ll play a vital role in supporting the leadership team to achieve project deliverables and take the helm in managing clinical studies, including task delegation, driving operational innovations, and fostering improvements within the team and projects.

Moreover, your expertise will extend to providing consulting services concerning the setup and execution of clinical studies conducted by local Country Business Units (CBUs). Your consultancy activities will encompass sharing industry best practices, reviewing and suggesting enhancements to protocols and accompanying documents, as well as outlining and supporting clinical study-specific processes such as 3rd party selection, CRO oversight, risk management, contract input, site selection, and startup.

Your capacity to lead clinical studies across various stages, from inception to overall progress and reporting, will be paramount. You’ll adeptly translate legislation and ICH-GCP guidelines into pragmatic, hands-on approaches while remaining cognizant of associated risks. Your ability to influence effectively, both internally within the company and externally with stakeholders such as CROs, central labs, sites, investigators, and Key Opinion Leaders, will be essential.

Key tasks/responsibilities:

• Establishing seamless collaboration within the multidisciplinary project team
• Driving innovation within the team and proactively seeking new implementations
• Ensuring highly complex studies adhere to GCP standards
• Coordinating regulatory and ethics submissions and approvals
• Selecting, collaborating with, and monitoring activities of clinical partners (CROs/sites)
• Providing comprehensive progress reporting on resources, budgets, and timelines
• Contributing to business strategy implementation within projects
• Maintaining daily alignment with team members
• Bringing novel insights to the company with a pioneering mindset

Your Profile:

• Master’s and/or PhD in life sciences or related scientific discipline
• Extensive experience in (international) clinical research
• Profound knowledge of legislation and ICH-GCP guidelines
• Ability to solve complex challenges with unique, agile approaches
• Capacity to share knowledge and expertise across different stakeholder levels
• Strong project management and passionate leadership skills
• Excellent communication skills in English and solid influencing skills to interact with internal and external stakeholders

Inge Breukink

Recruiter
Want to know more about the possibilities? Contact us.
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