International Clinical Trial Manager - European Eastern Countries
Syneos Health Clinical4.0
Remote
Job description
International Clinical Trial Manager - European Eastern Countries - (21003129)
Description


Clinical Operations Lead to work in our Oncology or General MedicineTeam! Open anywhere in Europe, regional or global role.

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
  • We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
  • 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
• Ensures quality of the clinical monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. May include the development of the Clinical Management Plan (CMP)/Site Management Plan (SMP).
  • Interacts with the client and other functional departments related to clinical monitoring and site management activities and deliverables.
  • Ensures alignment of clinical activities to budget, including identification of out of scope activities.
  • May participates in business development proposals, defense meetings and proposal development.
  • As required, provides development and delivery of initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study
  • May evaluate staff’s competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs)
  • Adheres to scope and routinely reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Data Visualization
  • Reviews the content and quality of site monitoring documentation.

#LI-MT1


Qualifications


 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.
 Knowledge of basic clinical project financial principles
 Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
 Must demonstrate good computer skills
 Excellent communication, presentation and interpersonal skills.
 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
 Moderate travel may be required, approximately 20%


Disclaimer:
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


Primary Location: Europe - POL-Home-Based

Job: Clinical Operations

Schedule: Full-time

Travel: Yes, 25 % of the Time

Employee Status: Regular

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