Syneos HealthClinical Trial Manager / Local Study Manager
Clinical Trial Manager / Local Study 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
For one of our sponsors we are looking for a Clinical Trial Manager to join the team here in Germany.
This Local Study Manager is accountable for the strategic planning & management and performance of the assigned clinical trials from country allocation within feasibility process until study closure. This includes study timelines, study budget, and study conduct in accordance with the sponsors 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. This position acts on country 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 different functions and other departments, e.g. Medical Advisor, Site Engagement Manager, Strategic Start Up Manager, Medical Science Liaisons. This role 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
Three years of experience in clinical research.
Experience in project management and certain time as field monitor or site coordinator.
International experienced preferred.
Fluency in German and English.
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Excellent communication, presentation and interpersonal skills
We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
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.