Senior Clinical Trial Regulatory Lead
Location: NetherlandsSIRE 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 Netherlands.
Our client is a professional Clinical Research and Pharmaceutical organization, based in Belgium. Our client is a professional Clinical Research organization. The client is a subsidiary of a global pharmaceutical company.
ROLE DESCRIPTION
The senior clinical specialist is responsible for developing processes and tools to support streamlined international disclosure for designated countries. This person acts as an expert to support all operational aspects of the clinical registry workflow in support of study registration and results disclosures on public websites for pharmaceutical companies. This person coordinates and monitors the registration of protocols and / or results in assigned countries. He ensures the quality of the global operations and data integrity of the Clinical Register and associated external websites by facilitating problem solving for new users and customers.
RESPONSIBILITIES
• Understand the global clinical registration landscape and customer needs.
• document the amended legal disclosure requirements for the designated countries
• Partner with relevant employees of the Local Business
• Assist with disclosure assessments for internal and external studies.
• Trace disclosure and other requests for international clinical registries,
• Participate in Clinical Registry Team Projects to Improve Processes and Technologies in Use
• Analyze the registration and disclosure data, if necessary
• Works with the operations team for selected tasks.
• Connect with stakeholders as needed during the disclosure process
REQUIREMENTS
- at least one BSc. In science or related
- minimum 5 years experience
- previous experience in a medical industry
- fluent in english
OTHER
- This position can be executed from Leiden or Beerse
- Travel may be necessary
- start date ASAP - until 31-12-2018
- Full-time position at multiple locations
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.
