Description:
Job Title: Clinical Study Administrator
Location: Belgum, Brussels area
Start date: ASAP

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Clinical Study Administrator to strengthen the team of one of Top 10 Pharmaceutical Companies.

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.

Job Description:
This individual will provide support to the clinical study staff within Clinical R&D department, as well as fostering strong, productive relationships with colleagues.

You will be responsible for processing, tracking, and filing of study documents, and management of the Trial Master File (TMF) within the clinical projects. In addition, administratively support clinical study staff as required.

Supports project managers within the assigned clinical studies.

Key Job Activities:

• Clinical Administration Tasks - (includes (one)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 (one)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 (one) CTMS and routing for internal approval)
• Participates in process improvement activities related to (one) CTMS/v-TMF within the department.

Job Qualifications:

• Minimum of a Bachelor's Degree is required.
• Previous clinical research experience a plus.
• Requires previous administrative support experience or equivalent for at least 1 year.
• Clinical/medical background a plus.
• Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word and Power Point)

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001887 . If you would like to discuss the role before applying through the website, please contact Julie.casteleijn@cromsource.com for more information.

Our benefits when working via TalentSource Life Sciences in Belgium:

• Dedicated Line Manager
• Employee satisfaction survey - your feedback is important for continuous improvement
• Annual appraisals development planning
• Yearly team event
• New Year's diner
• Group- and Hospitalisation insurance
• Electronic meal vouchers
• Internet reiambursement
• Company mobile phone (Depending on project)
• Car with fuel card (Depending on project)

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 Study Coordinator, Clinical Trial Administrator, Clinical Trial Assistant, Clinical Trial Coordinator Location: Belgium, Brussels