TFS HealthScience zoekt een Clinical Trial Associate in Zaltbommel | LinkedIn (2024)

TFS HealthScience is excited to be expanding ourStrategic Resourcing Solutions (SRS)team and we are looking for an experienced, highly motivatedClinical Trial Assistant (CTA)who shares our vision of providing clinical research excellence. Our team is a highly experienced international group of professionals led by an industry expert.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organisation.

Together we make a difference.

TFS HealthScience is looking for aClinical Trial Assistant based in the Netherlands. This is a hybrid role requiring 2-3 days/ week at the office (the Hague).

The Clinical Trial Associate (CTA) is part of the Clinical Operations or Strategic Resourcing Solutions Unit within TFS Develop and will work, when delegated, as a member of the study team with the responsibility to organize and maintain the Study Master File (SMF) and coordinate practical tasks during the study according to company policies, SOPs and regulatory requirements.

We look forward to receiving your application soon!

What can we offer you?

A great place to work where you will get the chance to push your career to the next level, a global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients.

Requirements

• Assists in the coordination and administration of clinical studies from the start-up to execution and close-out.
• Collects, assists in preparation, reviews and tracks documents for the application process.
• Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
• Interfaces with Investigators, external service providers and CRAs during the document collection process to support the effective delivery of a study and its documents.
• Serves as the local administrative main contact and works closely with the CRAs and/or the LSM for the duration of the study.
• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH- GCP and local requirements.

• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
• Ensures that all study documents are ready for final archiving and completion of the local part of the eTMF and supports the CRA in the close-out activities for the ISF.
• Contributes to the production and maintenance of study documents, ensuring template and version compliance.
• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.
• Sets up, populates and accurately maintains information in TFS tracking and communication tools (e.g. CTMS such as IMPACT, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems)

Requirements

• Bachelor’s Degree preferred
• Knowledge of GCP/ICH guidelines
• Good written and communication skills
• Good organizational skills
• Good software and computer skills
• Able to work in a fast-paced environment with changing priorities.