Clinical Trial Manager II – client-based, in Poland

Description

Clinical Trial Manager II 

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

• Under the operational direction of Clinical Country and Site Management (CCSM) personnel, perform GCO defined, country, site, and CRO sponsor oversight activities, including SOVs, to ensure high quality execution of clinical trials and highlight local opportunities to drive operational excellence.
• For assigned studies or sites, act as a country level ‘GCO ‘sponsor’ contact, establishing and maintaining excellent working relationships with local CRO staff and ensuring aligned, appropriate, and timely exchange of information and resolution of escalated issues between all stakeholders. This may include attendance at site visits outside of SOVs (e.g. SIVs, SSVs).
• For assigned studies or sites, CTM works with CCSM, Strategic partner CRO, and global teams to provide required information as part of defined country and site selection processes.
• Support CCSM in maintaining accurate contact lists, calendar information, local clinical operational intelligence (including regulatory) and update tracking systems as needed.
• Other assigned activities per Clinical Country Management delegation and assignment

Qualifications

What we’re looking for

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  Demonstrated ability to lead and align teams in the achievement of project milestones
  Demonstrated capability of working in an international environment
• Previous CRA experience is required
•  Demonstrates understanding of clinical trial management financial principles and budget management
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills
• Good communication, presentation and interpersonal skills among project team and with sites
• Strong conflict resolution skills
• Demonstrated ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
• Travel required 40% +
• Experience in Neurology and Immunology trials preferred

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.

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. At times, we take into consideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.