Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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 a Clinical Trial Coordinator. This role is hybrid, based at out Netherlands office in Ede.
As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Senior 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.
A Day in the life:
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:
Bachelor's degree preferred in life sciences.
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 or French in addition to English language and grammar skills
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
About PPD clinical research business of Thermo Fisher Scientific: Our mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today!