Global Clinical Trial Leader
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands.
- Responsible for delivery of assigned programs within agreed budget
- Overall Contract Management
- Track project progress against scheduled timelines
- Monitoring patient enrollment at global and or regional level
- Documentation and communication of project progress
- Maintaining project compliance within all applicable regulations, guidelines, internal SOPs and processes of the Health Authority (HA)
- Ensure correct reporting of AEs / SAEs / PQCs within the specified time
- Maintaining complete, accurate and timely data and essential documents in systems used for program management to ensure readiness for inspection
- Proactively identifies and manages problems in time
- 8+ years experience in Clinical Research in a Pharmaceutical environment
- Projectmanagement skills
- Able to work with ICH-GCP, SOPs, local regulations, protocols and specific procedures
- Excellent IT skills in relevant software and company systems
- Fluent in English (oral and written)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Bram Reulen.
The Company
They are a Biopharmaceutical company that specializes in the development of vaccines to cure infectious diseases worldwide.Role Description
You will be responsible for end-to-end operational management of data generation activities or managed access requests (including, start-up, execution, close-out, analysis and reporting according to planned timelines and budget, quality standards and regulatory requirements). Leading program teams on a global, regional level or local level.Responsibilities
- Point of contact for end-to-end operational management of the assigned programs- Responsible for delivery of assigned programs within agreed budget
- Overall Contract Management
- Track project progress against scheduled timelines
- Monitoring patient enrollment at global and or regional level
- Documentation and communication of project progress
- Maintaining project compliance within all applicable regulations, guidelines, internal SOPs and processes of the Health Authority (HA)
- Ensure correct reporting of AEs / SAEs / PQCs within the specified time
- Maintaining complete, accurate and timely data and essential documents in systems used for program management to ensure readiness for inspection
- Proactively identifies and manages problems in time
Requirements
- BSc degree or higher in Life Sciences- 8+ years experience in Clinical Research in a Pharmaceutical environment
- Projectmanagement skills
- Able to work with ICH-GCP, SOPs, local regulations, protocols and specific procedures
- Excellent IT skills in relevant software and company systems
- Fluent in English (oral and written)
Other information
Able to travel occasionally and spend the night according to business needs.Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Bram Reulen.
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