Clinical Trial Coordinator - FSP

Senior Clinical Trial Coordinator

About Us

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. Join our global team and make an impact at the forefront of innovation.

Role Overview

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

Key Responsibilities

Depending on the specific role (Central or Local), you will:

• Coordinate, oversee, and complete functions on assigned trial activities as detailed on the task matrix.
• Perform department, internal, country, and investigator file reviews as assigned and document findings in appropriate systems.
• Ensure allocated tasks are performed on time, within budget, and to a high-quality standard. Proactively communicate any risks to project leads and line manager as appropriate.
• Support maintenance of study-specific documentation and global support with systems, tools, and trackers including: study team lists, tracking project-specific training requirements, system access management for organization/vendor/clients, and tracking project-level activity plans. Ensure (e)TMF is up to date by following file review schedules and documenting findings.
• Provide system support (e.g., GoBalto & eTMF).
• Support RBM activities.
• Perform administrative tasks on assigned trials including: timely processing of documents sent to Client (e)TMF, performing (e)TMF reviews, mass mailings and communications, and providing documents and reports to internal team members.
• Support scheduling and organization of client and/or internal meetings and complete related meeting minutes.
• Review and track local regulatory documents.
• Transmit documents to client and centralized IRB/IEC.
• Analyze and reconcile study metrics and findings reports. Assist with clarification and resolution of findings related to site documentation.
• Maintain vendor trackers.
• Assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assist with study-specific translation materials and translation QC upon request.
• May attend Kick-off meetings 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 providing 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.

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 English language and grammar skills; proficient local language skills as needed.
• 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.