Clinical Study Administrator

Location: Belgium

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Brussel Belgium.

The organization is well-known for operating in Medical Devices and Pharmaceuticals worldwide.

ROLE DESCRIPTION

You will provide support to the clinical study staff within the Clinical R&D department, as well as fostering strong, productive relationships with colleagues within the Clinical R&D organization. Furthermore, you will be responsible for processing, tracking, and filing of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support clinical study staff as required.

RESPONSIBILITIES

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).

Other Administrative Tasks:
• 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.

REQUIREMENTS

• Minimum Bachelor's Degree in a related field.
• Previous clinical experience is a plus.
• Previous administrative support experience or equivalent for at least 1 year is required.
• Clinical / Medical background is a plus.
• Requires experience and knowledge of working with computer systems (Microsoft Office).
• Excellent written and verbal communications.
• Attention to details.
• Organizational skills.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Mitchell Jonk.