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08.04.2016

Site Monitor

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 and Pharmaceutical organization, based in Utrecht Netherlands.

Our Client is a multinational bio-pharmaceutical company. Their goal is to discover, develop and deliver innovative medicines to help patients to overcome the most severe illnesses

ROLE DESCRIPTION

In this role you will identify, evaluate, recommend new potential investigators/sites and you will expedite the pre-study and study initiation processes. Besides this you will review site activities through visits (on-site and off-site) and contacts the monitor study sites.

RESPONSIBILITIES

- Ensure quality of data submitted from study sites and assures submission of data according to timelines
- Ensure safety and protection of study subjects according to the monitoring plan, BMS SOPs, and ICH and/or FDA/GCP guidelines
- Manage overall activities of site personnel
- Provide monitoring assistance to colleagues
- Prepare and submit written reports, both monitoring and administrative (timely, accurate, concise, tactful and objective)
- Interact and builds relationships with all study personnel
- Resolve most study-related issues independently, with management support.

REQUIREMENTS

- Advanced and thorough knowledge of ICH GCP and/or FDA GCP regulations, and applicable local regulations.
- Dutch and English (Fluent)
- 2 to 3 years experience as Site Monitor; with excellence in on-site monitoring of interventional investigational drug trials
- Attention to detail, strong interpersonal skills, excellent verbal and written communication skills
- Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment
- Strong ability to work independently
- Critical thinker, critical communicator and positively dealing with resistance

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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