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06.09.2016

Global Study Specialist

SIRE 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 internationally acting Clinical Research Organisation specialised in assisting Biotechnology and Pharmaceutical industries

ROLE DESCRIPTION

Our client is looking for a Global Site Specialist to assist their client team. This role is concerning a permanent and fulltime position

RESPONSIBILITIES

- First point of contact with the clinical research sites during study start-up site activities
- Collaborate with clinical research sites to assemble the necessary investigator and regulatory documents for each relevant study
- Guarantee that the investigator and regulatory documents meet the requested specifications applicable to the regional regulations and ICH-CGP
- Update the study database concerning site address and information of personnel
- Supervising the regulatory documents throughout the complete process until the end of the clinical trial
- Collaborate with Operational Strategy & Planning, Business Development and Operations personnel to generate evidence-based plans for the successful implementation and conduct of global clinical trials by using feasible data
- Grant the logistics support of the clinical trial supply coordination

REQUIREMENTS

- Educational background: University degree, or relevant equivalent degree (life sciences related field preferred) and 2 years of experience within the industry of clinical research
- Or alternatively: a high school degree in combination with minimal 4 years of working experience in clinical research
- Fluency in the languages English, Dutch and French
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites
- Abilities to review/analyse relevant data so as to assist in building evidence-based clinical trial strategies
- Self-motivation with the ability to work under pressure to meet deadlines
- Works well independently as well as in a team environment
- Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
- Good organisational and time management skills
- Excellent communication I writing skills
- Strong computer skills with an ability to access and leverage technology alternatives
- Detail and process oriented.
- Positive attitude and approach
- Multi-tasking capability
- Ability to work independently

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Hanneke de Koning.



 
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