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05.09.2016

Local Start-up 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 and Pharmaceutical organization, based in Brussel Belgium.

Our client is a global CRO providing services for the pharmaceutical industry.

ROLE DESCRIPTION

In this role you will be independently responsible for the conduct and facilitation of specific start-up activities (identification, feasibility, SRP collection, review and approval, negotiate Clinical Site Agreements, perform ICF customization, IRB/EC and MoH/RA Submissions and assume country coordinator activities on study level on small projects, with a high accountability on quality and timelines.

RESPONSIBILITIES

- Maintain appropriate clinical trials management system
- Effectively plan and meet site activations
- Assist with QC/audit of central files, coordinate resolution plan, and liaise with Research Regulatory Compliance (RRC) personnel as required
- Effectively conduct feasibility and/or site pre-qualification activities:
- Perform review and validation of site identification list
- Review recruitment plan with site personnel
- Collect and negotiate Confidentially Agreements
- Adapt, collect, review and approve country specific and/or site specific documents
- Prepare and submit IRB/EC application until final approval received (initial submission/ Amendments)
- Follow-up on site related questions or outstanding documents

REQUIREMENTS

- Degree in a life science, nursing qualification, business, legal or other relevant experience, such as clinical, regulatory or contract negotiation experience
- Native Dutch, or very high level of Dutch
- Strong in written and oral English
- Shows commitment to and performs consistently high quality work
- Strong negotiation and diplomacy skills
- Strong computer and internet skills
- Strong knowledge of GCP and local regualtions
- Ability to effectively prioritize multiple tasks and consistently achieve project timelines
- Excellent interpersonal, verbal and written communication skills
- Client focused
- Pro-active
- Sense of urgency in completing assigned tasks

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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