Local Study Manager Belgium
il y a 2 semaines
Updated: December 20, 2024
Location: Belgium-Europe - BEL-Home-Based
Job ID: 24006876
Currently we are recruiting for a Local Study Manager (Clinical Trial Manager) to join one of our FSP partnerships.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
Job Responsibilities:
The Local Study Manager (LSM) is part of the Clinical Study Unit (CSU) and is accountable for the strategic planning & management and performance of their assigned clinical trials in The Netherlands within feasibility process until study closure inclusive archiving at the CSU level including study timelines, study budget, and study conduct in accordance with companies SOPs and ICH/GCP and regulatory guidelines & directives. This includes the ability to identify and anticipate risks jeopardizing the trial performance and to develop and initiate countermeasures based on proposer planning and regular revision of the plans. The LSM is working cross-countries or cross-clusters and covers satellite countries as well. For studies with no RSM assigned, LSM may assume partially RSM tasks as needed. The LSM acts on country/cluster level as the key strategic interface with internal and external stakeholders to develop, implement, maintain, and improve operational processes to accelerate trial conduct in close collaboration with respective functions within CSU and other departments, e.g. Medical Advisor, Site Engagement Manager, Strategic Start Up Manager, Medical Science Liaisons. The LSM acts as person of contact within a therapeutic area in terms of study management and conduct and leads a study team through change management efforts and by example.
Qualifications:
- Bachelor’s degree or higher degree in Health or Natural Sciences or equivalent experience
- Three years of experience in clinical research are mandatory, preferably in combination with experience in project management and certain time as field monitor or site coordinator.
- International experience preferred
- Preferred experience with risk-based monitoring
- Demonstrates understanding of clinical trial management financial principles and budget management
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Fluency in Dutch and proficient in English
- Experience in Neurology / Multiple Sclerosis is preferred
- Location in The Netherlands with an office in Amsterdam
Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.
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