Clinical Trial Coordinator

ThermoFisher Scientific; Brussel Hoofdstad; Hybride; EUR 42 000 - 62 000; Plein temps

Résumé du poste

Thermo Fisher Scientific is seeking a Clinical Trial Coordinator for its Belgian Clinical Team. The role is hybrid based from our Brussels office and involves coordinating trial activities, supporting the Project Team, and acting as a cross-functional liaison.

You will train new staff during onboarding and contribute to process improvements. The ideal candidate will have a strong regulatory acumen, excellent organization, and fluency in Dutch and English, with MS Office and trial systems

Qualifications

• High/Secondary school diploma or equivalent with relevant qualifications.
• Bachelor's degree preferred.
• At least 4 years of related experience or equivalent.
• Equivalency examined case-by-case.

Responsabilités

• Coordinate and oversee trial activities per task matrix.
• Conduct file reviews and document findings in the system.
• Ensure tasks are on time, within budget, and high quality; escalate risks.
• Maintain study documentation and trial-specific trackers (eTMF, GoBalto).
• Provide administrative support for meetings and meeting minutes.
• Review local regulatory documents and transmit to clients and IRB/IEC.
• Analyze metrics and support issue resolution with cross-functional teams.
• Assist with ISF/Pharmacy binder materials and translation QC as needed.

Connaissances

Organizational skills

Communication

Team collaboration

Attention to detail

Problem solving

Regulatory knowledge

Dutch-English fluency

MS Office

eTMF systems

Formation

High/Secondary school diploma

Bachelor's degree preferred

Equivalency acceptable

Outils

MS Office

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 with our Belgian Clinical Team. The role is hybrid based from our Brussels offcie.

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.