Clinical Trial Assistant - Ghent region - Sponsor dedicated
- Experience Level
- Experienced (non-manager)
Upsilon Global have partnered with one of our frequent CRO collaborators who are seeking a permanent CTA to work sponsor dedicated for an exciting, growing Biotech who have a strong focus on immunology and immuno-oncology.
- You will work on Clinical Trials by assisting the Clinical Trial Manager(s) (CTM) with the conduct of the assigned clinical trial(s) (administration, coordination, archiving)
- May assist the Clinical Operations Lead (COL) with organizing the Clinical Team Meetings
- Help the Head of Clinical Operations with the development of template documents to be used within the Department as well as with the logistics of the departmental meetings
- The CTA assists the CTM with the coordination of the logistical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Standard Operation Procedures (SOPs)
- Assists with signature collection for CDAs, contracts, POs and insurance certificates in collaboration with CTM/Director Vendor Management
- Develops and adapts documents to trial specific requirements in collaboration with the CTM
- May assist with the preparation of trial reports for the trial team and keeping them up-to-date
- Assists with organizing (agenda, meeting minutes, follow-up on action items) trial specific meetings, including but not limited to trial team meetings, Investigator Meetings.
- Assists the CTM/COL to ensure that the essential Trial Documents at sponsor level are properly filed and made ready for archiving.
- Provides input to the other departments outside Clinical Operations to ensure that the needed documents are filed within the (e)TMF.
- Assists in (electronic) Trial Master File review (TMF) to confirm completeness and follow-up of findings
Education And Qualifications
- Minimum of 3 years of experience as a CTA
- Speaks and writes English fluently, any additional level of Dutch would be beneficial, but not essential
- Knowledge of ICH-GCP
- Knowledge of (e)TMF
- Proficient in software applications such as Outlook, Word, Excel and PowerPoint
- Experience with tools and systems for managing clinical trials such as MS project, trial progress and metric systems, eCRF, IXRS
- Experience of working within a Biotech would be beneficial, but not essential
- You must be based within a commutable distance to Ghent is this role is part office/part home based once we are post COVID-19
Please don't hesitate to get in contact with me on +44 203 875 9966 or firstname.lastname@example.org for any further questions you may have about the vacancy!
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