Clinical Study Assistant

7-12-2018 diegem

Do you want to contribute to a large-scale project and have an impact on the world around you?

Johnson & Johnson (J&J) is the world¿s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and professional markets. Products are sold throughout the world and serve a broad segment of medical needs ranging from baby care, first aid, and hospital products to prescription pharmaceuticals, diagnostics, and products relating to family planning, dermatology, and feminine hygiene. `Caring for the world, one person at a time'... inspires and unites the people of Johnson & Johnson. The Company¿s ambitious mission is to humanize health and wellness care; help people live better, longer, happier lives; democratize access to care; and drive dramatically lower costs will require bold, innovative applications of technology.

Our company works together with hospitals and other organizations by providing medical products, instruments and services. With approximately 150 employees Johnson & Johnson Medical is one of the largest healthcare suppliers in Belgium.


The Clinical Study Assistant will provide support to the clinical study staff within the Clinical R&D COE:

Supports project managers within the assigned clinical studies and is responsible for processing, tracking, and filling of study documents, and management of the Trial Master File within the clinical projects. In addition, administrative support.

Key job activities - Clinical study administrative tasks:

* 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, department 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.
* supports ongoing use of CTMS.
* Assist in tracking of study activities as applicable and documents relating to such activities.
* Coordinate with clinical project managers/ leaders and site monitors for site concerns/issues.
* Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
* May be involved in other tasks to support Clinical Operations

Other administrative tasks:

* study supplies ordering, shipment, tracking and distribution, if needed
* assistance with logistics for investigator meetings/ expert panel meetings
* assistance with distribution of news letter (create mailing list from CTMS and routing for internal approval)
* participates in process improvement activities related to CTMS/v-TMF within the department

This job is temporary: the position has been approved for 12 months and will probably be extended.

jouw aanbod

* minimum of Bachelor's Degree is required
* excellent communication skills in English
* experience in clinical study field is required: recent trial master file (e-TMF) exposure or experience is required
* clinical/ medical background or experience is a plus
* profound knowledge of MS Office (Excel, Word and PowerPoint)
* demonstrated competencies in the following areas are required: tracking, written and verbal communication skills, attention to details, organizational skills

wat bieden wij?

The identified candidate will be offered a job of minimum 12 months and a comptetitive salary completed with meal vouchers of €7, a reimbursement of your travel expenses, eco-cheques and 1 additional paid holiday per month (ADV/RTT).

paramedisch (m/v)
tijdelijke opdracht
Groot- en detailhandel
contact informatie
Caroline Temmerman 025066259