Trial Coordinator in Belgium
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Clinical Research organization, based in Belgium.
Internationally big company which is looking for a new employee
ROLE DESCRIPTION
This individual will be responsible for leading one or several clinical trials within the Clinical R&D department, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the trial leader for clinical study execution.
RESPONSIBILITIES
• Serve as a Clinical Trials Leader within the Clinical R&D department to execute company sponsored clinical trials for the Medical Device Franchises
• Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
• Serves as a member of the clinical trial/study/program core team and may serve as the liaison with the Clinical R&D Franchise and Clinical R&D BSDM for projects under his/her responsibility
• May serve as the primary contact for clinical trial sites
• Independently solves problems arising during clinical study execution, and will seek guidance for more complex problems, as needed
• Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
• May be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed
• Plan, track, and manage assigned clinical trials/programs budgets to ensure adherence to business plans
• Support the implementation of new clinical systems/processes, and provide support for publications, as needed.
• Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
• Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
REQUIREMENTS
• Requires knowledge of Good Clinical Practices
• Knowledge and understanding of application of regulations and standards applied in clinical areas/regions.
• Effective leadership skills in a professional and ethical manner
• Strong Written and oral communication skills
• Demonstrated competencies in the following areas are required:
• Behave and lead in a professional and ethical manner
• Presentation skills and influencing of others
• Advanced technical writing skills
• Advanced project management skills with ability to handle multiple projects
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• BSc with at least 6 years, MSc with at least 5 years, PhD with at least 3 years of relevant experience preferred.
• Previous experience in clinical trial management or equivalent is required.
• Experience working well with cross-functional teams is required.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
• Experience managing others, a plus.
• Clinical/medical background a plus.
• Medical device experience a plus.
OTHER
2 days home based is an option.
looking for someone ASAP
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Romy van Ooijen.