Sofie Van Calster
Teamlead Upgraded at Texet Benelux- Claim this Profile
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Dutch Native or bilingual proficiency
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English Professional working proficiency
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French (following course) Elementary proficiency
Topline Score
Bio
Experience
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Texet Workwear
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Belgium
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Textile Manufacturing
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1 - 100 Employee
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Teamlead Upgraded
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Feb 2021 - Present
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Specials Administrator , Texet Benelux
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Oct 2017 - Aug 2021
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Logistics and buying coordinator
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Apr 2014 - Aug 2021
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The Janssen Pharmaceutical Companies of Johnson & Johnson
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Project Coordinator/Clinical Data Monitor
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Oct 2013 - Jun 2014
- Sets up the related project master files for administration. - Contributes in the set-up and monitoring of new Research assays which require extra attention and a flexible approach. - Ensures adequate communication with the data manager regarding Sponsor/Client specific data management questions and set up. - Ensures adequate communication with Sample Reception for the preparation of new assigned Janssen Diagnostics BVBA projects. - Sets up start-up meetings to inform all in-house staff on upcoming Janssen Diagnostics BVBA projects. - Is first point of contact for all Janssen Diagnostics BVBA dedicated projects and maintains client satisfaction. - Ensures blinding/un blinding methods are strictly adhered to, if applicable. - Ensures follow-up and reporting of all Research (RUO) datasets and non-Research data sets (validated). - Is responsible for the initiation of Work orders and makes sure all RUO samples are started in our lab process, according to client agreements. - Works closely with the lab to continuously align lab capacity with client expectations. - Aligns with the lab on a daily basis for priority setting. - Ensures that agreed turn-around-times (TAT) for result reporting is respected. If needed, clarifies reasons for sample analysis delays and/or takes pro-active measurements. - Sends or ensures sending of laboratory result reports or laboratory results. - Ensures return of destruction of stored/archived specimens. - Ensures final invoicing. - Prepares Project overview reports for departmental meetings. - Keeps track of timelines for projects. - Reports any issues related to the services offered to the Hierarchical Supervisor. - Creates monthly KPI overviews for evaluation of lab performance. - Ensures confidentiality of patient related information (data privacy). - If applicable, acts as back-up for the Data Information Manager (DIM). - Ensures application of all policies, SOP’s, WI’s and other guidelines - etc... Show less
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PPD
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United States
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Research Services
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700 & Above Employee
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Project Management Assistant
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Dec 2011 - Aug 2013
- Preparing Investigators Meeting Presentation- Placing initial supplies and managing re-orders- Liaison for daily questions ISS/Lab/SCM/logistics: follow-up with the departments on daily questions and help the PM with managing email communication.- Gathering all documentation required for regulatory submissions and import/export license- Attending smaller Investigator Meetings when PM availability is an issue- Prepare documentation and binders for audits- Following up at study closure- Assistance on managing/reviewing listings that are required based on study specifics- Assistance in reviewing and creating site deliverables- Backup attendee for TC’s when the PM is out of the office- Attend meetings and training and make Meeting Minutes- Assisting in budget revieuws and monthly invoices- Providing the necessary documents to complete all site addresses... Show less
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Investigator Services Assistant
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Apr 2009 - Nov 2011
• Handling incoming calls from sites/CRA’s• Handling problem samples• Working with SYS2000 for old studies• Working with Connexion for new studies• Close exception and refaxed open exceptions• Handling daily QC for old studies• Reviewing DM listings and make corrections• Clean the database in SYS2000 and Connexion for study closures• Follow up daily Connexion reports• Handling VAV’s...
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Data Coordinator/Administrator Assistant
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May 2006 - Mar 2009
• Handling incoming calls from sites/CRA’s• Handling problem samples• Working with SYS2000• Handling daily QC for incoming samples• Reviewing DM listings and make corrections• Clean the database (SYS2000) for study closures• Handling incoming reception calls• Welcome visitors• Filing• Entering site/CRA information• Refax failing faxes• Handling VAV’s...
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Education
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Sancta Maria Leuven
High School, Youth and disabled care