Clinical Study Specialist

Clinical Study Specialist

at ClinChoice (View all jobs)
Diegem, Belgium

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds....

ClinChoice, is searching for a Clinical Study Specialist to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work in a hybrid model in Diegem, 1.0 FTE permanent contract.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Scope of the role:

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

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. Supports project managers within the assigned clinical studies.

Main Job Tasks and Responsibilities:

• 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/vTMF within the department.
• May provide other administrative support for clinical study or departmental activities as needed and assigned by supervisor or study leaders.

Education and Experience:

• 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).

Specific Role Requirements and Skills:

• Tracking.
• Written and verbal communications.
• Attention to details.
• Organizational skills.
• Fluent in English and Dutch (spoken and written).

Our Benefits:

• Competitive Salary.
• Group and hospitalisation insurance.
• Electronic meal vouchers.
• Internet reimbursement.
• Excellent work-life balance.
• Dedicated Line Manager.
• Full performance and development process with end of year reviews.
• Career opportunities within in ClinChoice, locally and globally.
• Employee satisfaction survey - your feedback is important for continuous improvement.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice 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 the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Clinical Study Specialist, Clinical trials, ICH-GCP, TMF, CTMS, Tracking, English, Dutch, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

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