We are looking for a driven and ambitious colleague that will be responsible for administrative, logistics and operational support to the Clinical Operation team. This position will function under the guidance and direction of the Head of Clinical Operations. The successful candidate will be autonomous and proactive with experience in working in a clinical environment.
Main activities are:
Clinical Administration Tasks (includes CTMS build and tracking, v-TMF build & upload)
Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
Creation/distribution of regulatory binders & the wet-ink signed documents binder
Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing corrective and preventive actions.
Assist in providing internal communication of important clinical data and events.
Support ongoing use of CTMS by maintaining and tracking relevant activities.
Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
May be asked to provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs
May be asked to assist with Device tracking and ordering if required and if applicable.
Assistance with logistics for Investigator meetings/expert panel meetings
Assistance with distribution of newsletter (create mailing list from CTMS and routing for internal approval)
Participates in process improvement activities related to CTMS / v-TMF within the department.
In addition to the responsibilities above, the senior CSA can also assist in the following tasks:
May provide other administrative support for clinical study or departmental activities as needed and assigned by supervisor or study leaders
Qualifications
Written and spoken fluency in Dutch and/or English
Proficient in software applications such as Outlook, Word, Excel and PowerPoint
Demonstrated competencies in the following areas are required: Tracking, Written and verbal communications, Attention to details, Organizational skills
Clinical experience as well as (v)TMF experience is a plus
Knowledge of ICH-GCP and EU Directives applicable to Clinical Trials would be even better!
What we offer:
We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers , eco vouchers, mobile phone (data included)
We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...)
Side activities will be organised regularly, to achieve a close collaboration within our team
We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
We contribute to a number of charities & support the research and / or the patients in our industry.