Description:
Job Title: Senior Clinical Trial Assistant

Location: Netherlands, Leiden

Schedule: Full time, Permanent

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Senior Clinical Trial Assistant for one of our clients based in the Leiden area of the Netherlands.

For our client-facing positions, you must be confident and be able to drive the role and yourself and to work autonomously. You will have a close relationship with our Line Managers, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on studies for just one client. We are open, friendly and approachable and aim to support you through the recruitment process every step of the way.

Main Job Tasks and Responsibilities

• Cooperates with the project team, accurately updating and maintaining clinical tracking systems
• Responsible for the preparation, handling, distribution, collection, filing and archiving of clinical documentation and reports
• May act as Feasibility Associate (FEA) after appropriate and documented training
• Collaborates with the project team on the preparation, handling and distribution of clinical trial supplies and maintenance of tracking information (logistics of the project)
• Supporting Clinical Study Leads in proper TMF management, review (i.e. Quality checks delegated to CSAs) and archiving (coordination, consolidation of TMF documents).
• Prepares and requests the necessary local authorities approvals
• May support the project team in managing the agreements with hospitals and investigational centers
• Assists with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
• Collaborates with the project team in organizing Investigator's and Monitor's Meetings
• Collaborates with the project team in managing the follow-ups of the monitor's activities
• Manages the telephone monitoring of projects
• Collaborates with the project team in managing the payments of sites
• May perform submissions to local ECs and CAs

Education and Experience

• University Degree in scientific medical or paramedical discipline
• Up to 5 years of Clinical Research experience in the CRO/Pharmaceutical industry
• Good Knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
• Fluent in English
• You have strong computer literacy including proficiency in MS Office software programs (Excel, Word and PowerPoint). Experience with SharePoint, eTMF and CTMS systems is preferred.

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001828 . If you would like to discuss the role before applying through the website, please contact Julie.casteleijn@cromsource.com for more information.


The Benefits of Working for TalentSource in The Netherlands

• Competitive Salary
• Group health insurance
• Great pension scheme
• 25 Holidays per annum
• Internet reimbursement
• Company Car with fuel card depending on the function
• Dedicated Line Manager
• Monthly meetings with line manager
• Full performance and development process with end of year reviews
• Team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

Why choose TalentSource Life Sciences/CROMSOURCE?

TalentSource Life Sciences is a fully dedicated flexible resourcing department at CROMSOURCE, a family owned international, full-service Contract Research Organisation. CROMSOURCE comes from the merger of MSOURCE and CROM and we have been supporting clients with outstanding clinical research and resourcing services since 1994. Successful growth has been achieved by putting high quality and client focus at the heart of everything we do and we are proud to partner with industry leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide.

Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our current below industry average turnover rates.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are experts providing experts - highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world.

Skills: Clinical Trial Administrator, Clinical Trial Assistant, Clinical Trial Coordinator Location: Netherlands