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 companyOur client is a professional Clinical Research and Pharmaceutical organization, based in Netherlands. Our client is a professional Clinical Research and Pharmaceutical organization, based in Belgium. The company is a pharmaceutical company headquartered in Beerse, Belgium which conducts research and development activities related to a wide range of human medical disorders, including mental illness, neurological disorders, anaesthesia and analgesia, gastrointestinal disorders, fungal infection, HIV
Role descriptionThis role will provide support to the Clinical Supply Integration staff within Pharma R&D, as well as fostering strong, productive relationships with colleagues within the Clinical Supply Chain organization and its stakeholders. You will be responsible for processing, tracking, and filing of study documents within the clinical projects. You also wil support project managers within the assigned clinical studies.
Responsibilities• Under general supervision, accountable for the timely processing and tracking of study essential documents for assigned clinical studies according
to appropriate regulations, departmental guidelines, and work instructions.
• Prepare and coordinate review and approval of Distribution Plans for all new Clinical Trials.
• Proactively request new clinical trials to be added to Distribution database
• Create Distribution Plan, coordinate review meetings with depots/CSIs, make updates to plan and route for approvals, review distribution quotes
and prepare for CSI review, route final quotes for approval and initiate PO process. Communicate PO numbers to all depots and ensure all approved
versions of Distribution Plans are posted in appropriate repository.
• Coordinate 3rd Party Requests
• Obtain SMPC and post in appropriate repository
• Create requests for technical documents on CSI sharepoint site follow up with expert team to ensure timely completion
• Ensure sharepoint site is kept up to date with TD numbers as well as status
• Manage sharepoint for changes as needed
• Single Point of Contact for Quality Events for CSI team
• Attend weekly quality meetings to provide updates on CSI owned records
• Follow up with CSI team (as needed) to ensure timely completion of records
• Once trained, act as SPOC for all records for CSI (Open, pre-populate, manage) and then work with impacted CSI to add issue specific content
• Develop system to manage processes within CSI team:
• Track upcoming periodic review and notify team
• Routing updates to WIs/SOPs through docspace and gaining approvals
• Create standard set of training material to be used across CSI team for all process updates.
• Assist with management of the following items on behalf of the CSI team:
• Obtaining release documents/bulk lot information for filings/CSRs
• Sample shipment tracking for development work
• CSI sharepoint maintenance/changes/enhancements
• Perform Quality Review in vTMF
• Complete Temperature Intake Form on behalf of CSI
• May be involved in other tasks to support Clinical Supply Integration as needed.
Requirements• Requires experience and knowledge working with computer systems (Microsoft office – Excel, Word, Power Point and Sharepoints).
• Good knowledge of clinical research and operations
• Good knowledge of GXP
• Minimum 80% FTE required for the job
• Results and Performance Driven
• Big Picture Orientation with Attention to Details
• Ability to collaborate internally and have seamless
• Ability to work in cross cultural environment
Very good knowledge of the English language.
Other informationThis is a project in Beerse starting from ASAP to 30/04/2018
40hours a week and office based