Clinical Trial Operations Specialist - The Netherlands or Belgium

Description

For one of our sponsors we are currently recruiting for a Clinical Trial Operations Specialist to be hybrid-based in The Netherlands or Belgium.

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.

The Clinical Trial Operations Specialist (CTOS) is a key member of the Clinical Trial Team and is accountable for clinical trial execution excellence including any of the following:

• Planning, coordination and conduct of complex, regulatorily defined tasks
• Seamless trial operation and communication to all applicable stakeholders
• Timely delivery of all the materials, documentation and information needed to setup, execute and delivery of the assigned trial(s)
• Independently take care for complex technical systems to manage clinical trials in order to allow a correct reporting of trials to senior management
• Oversight of trial supplies, documentation, submissions, and other operational parameters

The CTOS works independently, but in close collaboration with Clinical Trial Leader (CTL) and other trial team members, liaising closely with other stakeholders for all trial-related issues, including support to regional/local trial activities where applicable.

Qualifications

What we’re looking for:

• University degree qualified and/or comparable professional education with at least 5 years experience in the area of clinical trials.
• Strong and proven track record with a background in administrative management of clinical trials
• Long-standing working experience in international context and cross functional project work.
• Strong clinical trial project management experience. In-depth understanding of project management with emphasis on team work to promote high-performance teams
• Understanding of major regulations (US FDA, EMA and PMDA)
• Good knowledge of ICH-GCP
• Cross geographical experience. Working in multi-cultural environment; strong understanding of corporate culture and cross-cultural dynamics
• Demonstrated competencies in Agility, Accountability, and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking.
• Confident user of Electronic Applications
• Possibility to work from the office (Amsterdam or Brussels), as well as from home.

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.