Senior Clinical Trial Coordinator

Join Us as a Senior 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.

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.

• 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.

Standard (Mon-Fri)

• 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

Office