Local Study Manager The Netherlands

Description

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. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical  and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

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. The LSM represents the LSM perspective for CSU in organization wide initiatives.

Qualifications

What we’re looking for:

• 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 experienced 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
  

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health

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.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.