Senior Clinical Study Manager in fulltime
XDES Projects - Utrecht
Senior Clinical Study Manager in Utrecht fulltime Board & Leadership, Clinical Operations Netherlands, Utrecht (stad) Fulltime V- Competitive For our client, a global research and development organization with over years of - Volledige vacature bekijken
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Senior Clinical Study Manager in fulltime
Board & Leadership, Clinical Operations
Netherlands, Utrecht (stad)
Fulltime
V-100967
Competitive
For our client, a global research and development organization with over 100 years of experience, focusing on our health in all life stages, we are looking for a Senior CTM.The Senior Clinical Trial Manager (Sr CTM) plays a critical role in both initiating and managing the operational aspects of (complex) clinical trials. Reporting to the Senior Team Leader for Explorative Clinical Trials, the Sr CTM assists in achieving team objectives and oversees clinical studies, including task delegation, driving operational improvements, and fostering innovation within the team and projects. Additionally, there may be future responsibility for managing a team of Clinical Trial Managers.
Key responsibilities include:
- Facilitating seamless collaboration within the multidisciplinary project team, comprised of Clinical Trial Researchers, Clinical Trial Assistants (CTAs), Data Management, Supplies, Quality, and Science.
- Leading innovation within the team by actively seeking new implementations and adjusting course when necessary.
- Ensuring that highly complex studies are set up and conducted in compliance with GCP standards, including arranging regulatory and ethics submissions and approvals.
- Engaging, coordinating, and monitoring the activities of clinical partners (CROs/sites).
- Providing progress reports on resources, budgets, and timelines.
- Contributing to business strategy implementation within projects.
- Maintaining day-to-day alignment with team members.
- Introducing fresh perspectives to the company with an innovative mindset.
We seek a Senior Clinical Trial Manager with:
- A Master’s and/or PhD in life sciences or a related scientific discipline.
- Extensive experience in (international) clinical research.
- Profound knowledge of legislation and ICH-GCP guidelines.
- Experience with (medical) nutrition is a plus.
- Demonstrated experience in team management.
- Proficiency in solving complex challenges using agile approaches.
- Strong project management skills and a passion for leadership.
- Excellent English communication skills and adeptness in influencing internal and external stakeholders.
- Aptitude for problem-solving and critical thinking.
Inge Breukink
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