Clinical Trial Coordinator- FSP (client dedicated) - Belgium or Netherlands

ThermoFisher Scientific; Brussel Hoofdstad; Sur place; EUR 42 000 - 64 000; Plein temps

Résumé du poste

Thermo Fisher Scientific is seeking a Clinical Trial Coordinator in Belgium to provide administrative and technical support to the Project Team. You will coordinate trial activities, maintain study documentation, and support onboarding and process improvements.

Required: high school diploma, 4+ years’ experience, and strong Dutch/English skills. Proficiency in MS Office and trial systems like GoBalto/eTMF is expected. Office-based role with possible travel within Belgium.

Qualifications

• High/Secondary school diploma or equivalent; Bachelor's preferred.
• Excellent organizational and documentation skills; strong communication in English and Dutch.

Responsabilités

• Coordinate, oversee and complete trial activities as per task matrix.
• Review and document regulatory and study-related materials in systems.
• Ensure tasks are on time and within budget; flag risks to leaders.
• Maintain study documentation and trackers; support training of staff.
• Attend meetings and take minutes when required.

Connaissances

Organizational skills

Attention to detail

Data analysis

Customer focus

Time management

Team player

Dutch & English fluency

MS Office

Clinical systems

Formation

High/Secondary school diploma or equivalent

Bachelor's degree preferred

Outils

GoBalto

eTMF

Description du poste

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

We have a vacancy for Clinical Trial Coordinator for our Client dedicated FSP team with our Belgian/Netherlands Clinical Team.

As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coordinator, you'll coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team. You will act as a buddy during the onboarding phase and provide training to new staff as needed. Additionally, you will support departmental and cross-functional initiatives for process improvements and enhancements.

What You’ll Do:

• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
• Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
• Provides system support (i.e. GoBalto & eTMF).
• Supports RBM activities.
• Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
• Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
• Reviews and tracks local regulatory documents.
• Transmits documents to client and centralized IRB/IEC.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Maintains vendor trackers.
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• May attend Kick off meeting and take notes when required.

Education and Experience Requirements:

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• Bachelor's degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Ability to work in a team or independently as required
• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
• Excellent Dutch and English language and grammar skills (ideally French also)
• Good presentation skills
• Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Ability to successfully complete PPD clinical training program
• Self-motivated, positive attitude with effective strong interpersonal skills

Working Conditions and Environment:

• Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential Occasional travel required

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.