Sr Clinical Trial Coordinator - UAE

Role Overview

Senior Clinical Trial Coordinator at Thermo Fisher Scientific, UAE. This is a Project Support Coordinator II role based in the United Arab Emirates.

Company Overview

Thermo Fisher Scientific has 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.

Role Purpose

Provide administrative and technical support to project teams, including planning, organizing, and coordinating responsibilities at a global level with minimal supervision. Proactively assist with initial setup and ongoing maintenance of various systems, complete data entry, maintain database repositories, prepare reports, collect data for analysis, and support audit readiness.

Key Responsibilities

Trial Coordination

• Coordinate, oversee, and complete functions on assigned trial activities detailed on the task matrix.
• Attend kick-off and project launch meetings as required, take notes, and support initial study setup.
• Ensure allocated tasks are performed on time, within budget, and to a high quality standard.
• Escalate cases of variances, including overburn or underburn.

Compliance & Audit Support

• Perform department, internal, country, and investigator file reviews as assigned and document findings in the appropriate system.
• Support audit readiness by ensuring files are reviewed on schedule as detailed in the organization's SOPs and client-specific guidance documents.
• Maintain audit readiness and communicate non-compliance to the study team.
• Demonstrate ability to attain and maintain good working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization or client SOPs and WPDs for all non-clinical and clinical aspects of project implementation, execution, and closeout.

Systems & Documentation Management

• Provide system support for CTMS, Oracle Activate, and eTMF by managing access requests, tracking study level documents, and maintaining audit readiness.
• Support maintenance of study-specific documentation and global support with specific systems, tools, and trackers, including study team lists, tracking of project-specific training requirements, system access management for organization, vendor, and clients, and tracking of project-level activity plans in the appropriate system.
• Perform administrative tasks on assigned trials, including timely processing of documents sent to CRG or client eTMF as required, performing CRG or client eTMF reviews, coordinating for issue resolution, performing mass mailings and communications as needed, and providing documents and reports to internal team members.
• Export and reconcile study metrics reports.
• Maintain vendor trackers.

File Preparation & Coordination

• Proactively assist with coordination and compilation of Investigator Site File (ISF) template and pharmacy binder with instruction from the Clinical Team Manager.

Meeting & Communication Support

• Support scheduling and organization of client and internal meetings with completion and distribution of related meeting minutes.

Training & Process Improvement

• Support training of new staff.
• Participate in functional group initiatives to support process improvements and enhancements.

Qualifications & Experience

• High school or secondary school diploma or equivalent and relevant formal academic or vocational qualification.
• Technical positions may require a certificate.
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 2 years.
• In some cases, an equivalency consisting of a combination of appropriate education, training, and directly related experience will be considered sufficient to meet the requirements of the role.

Skills & Competencies

• 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.
• Demonstrated ability to effectively analyze project-specific data and systems to ensure accuracy and efficiency.
• Strong customer focus.
• Good time management skills and flexibility to reprioritize workload to meet changing project timelines.
• Good English language and grammar skills and proficient local language skills if required.
• Effective oral and written communication skills with ability to communicate effectively with project team members.
• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint).
• Ability to obtain knowledge and learn required clinical trial systems.
• Ability to successfully complete CRG training program.
• Self-motivated, positive attitude, and good interpersonal skills.
• Arabic and English language skills required.

Additional Information

• Work Schedule: Standard Monday to Friday.
• Environmental Conditions: Office-based work performed in an office or clinical environment with exposure to electrical office equipment.
• Travel: Occasional drives to site locations. Potential occasional travel required.
• Candidate must already be based in UAE.