Clinical Trial Associate
4 weken geleden
September 4, 2024Location:
Netherlands-Europe - NLD-Home-BasedJob ID:
24004925For one of our sponsors, based in Amsterdam West, we are currently looking for a
Clinical Trial Associate.
In this role you will be providing support to project teams within the Clinical Development Centre (CDC) in The Netherlands for assigned clinical trials. Activities include all relevant aspects of preparation, execution, and finalisation of a clinical trial in order to facilitate the process towards timely clinical project deliverables of required quality.Why Syneos HealthWe are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self culture – where you can authentically be yourself.We are continuously building the company we all want to work for and our customers want to work with.Job Responsibilities:During Start-Up:Ensure timely delivery of (country specific) documents applicable for submission.Ensure timely responses to RFIs in collaboration with the project team.Set-up of Sponsor Trial Master File (STMF) tasks (Country and Site-specific documents) as per responsibility split between CTA (country specific docs) and CRA (site specific documents).Timely collection, filing and preparation for long term archival of site and country level trial documents in STMF according to country and company SOPs.Preparation and shipment of initial Investigator Trial Master Files (ITMFs).Enter initial information in relevant clinical IT systems (e.g. COSMOS, CONNECT Portal) as per responsibilities split.Perform quality control (QC) of trial documents such as review and translations, e.g. patient information.Ordering clinical supplies (e.g. booklets, equipment).Prepare and maintain study specific logs.Support in preparation of essential documents (e.g. clinical trial agreements), have them signed and handled in relevant systems.Conduct and Close-out stages:Ensure preparation and submission of changes to clinical trial application.Ensure timely responses to RFIs in collaboration with the project team.Maintenance of Sponsor Trial Master File (STMF) tasks (Country and Site-specific documents) as per responsibility split between CTA (country specific docs) and CRA (site specific documents).Ensure sufficient clinical supplies and adequate tracking.Support CRAs in distribution of trial documents to trial sites (e.g. Investigator Trial Master File, recruitment material).Update and maintain relevant information in the clinical IT systems (e.g. COSMOS, CONNECT Portal).Support organisation of local study related meetings (e.g. Investigator meetings).Support complaint handling of trial material.Active involvement in project meetings, for CTA related topics.Ensure timely and adequate STMF archiving at closeout.Functional Accountabilities:Oversight of all trial documentation for assigned clinical trials in close cooperation with TM/CRA/Start-up within the CDC.Ensure and drive consistency in CTA activities across projects and within CDC-NL.Qualifications:What we're looking for:An enthusiastic new colleaguePrevious experience within clinical trials.Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.Strong organizational skills and the ability to manage time and work independently.High proficiency with full MS Office Applications.Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.Fluency in Dutch and a high level of competence in English language.Ability to work from the Amsterdam office one or two days per week.Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
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