Study Operations Manager The Netherlands

Description

For one of our sponsors we are currently recruiting for a Study Operation Manager.

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 Study Operations Manager will have responsibilities for study and regional or specific country level activities from study startup through conduct and study close.
• The Study Operations Manager has responsibility for study management aspects of assigned studies of limited complexity (e.g. single country, a small number of countries/sites) or manage a unique part of a larger study (e.g. recruitment and retention).
• The Study Operations Manager will be assigned to one or more studies and will be tasked with taking on responsibilities in support of Global Study Managers, other Study Operational Managers and the larger Study Management delivery of the study.
• The Study Operations Manager may partner with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Country Trial Manager, Site Care Partners, Site Excellence Partners, Site Relationship Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out.
• The Study Operations Manager has comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team.
• The Study Operations Manager I may lead specific parts of the project or drive specific countries. They may help guide the Study Management strategy by inputting local intelligence and providing accurate updates on tasks delegated to them in order to support establishment of critical path activities and risks. They will ensure the operational delivery of responsible tasks within one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.
• The Study Operations Manager may be responsible to independently take on activities with instruction provided as needed. They may lead and guide the closing out of one or more studies of low complexity post database lock.

Qualifications

What we’re looking for:

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Demonstrated clinical research experience and/or study management/startup project manager experience
• Demonstrated experience in managing country level operational activities and/or vendors
• Expertise in the use of study/site dashboard and reporting tools
• Detail oriented & possesses technical expertise
• Ability to manage moderately complex processes
• Ability to operate in a matrix environment
• Risk Identification & Mitigation
• Strategic Planning, Analytical and Problem-Solving Skills
• Critical Path Analysis
• Excellent communication skills, both written and verbal
• Ability to adapt to changing technologies and processes
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
• Requires comprehensive knowledge of own discipline and good knowledge of others and applies these skills to ensure the study can meet its goals
• Supports an environment where innovation is standard taking appropriate risks to advance innovative processes
• Develops ideas and leads moderately complex projects
• Exercises own judgment and is a resource for others.

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.