CTM/Sr CTM FSP EMEA📣 إعلان

About the Role

Thermo Fisher Scientific is seeking a Clinical Trial Manager (CTM) or Senior Clinical Trial Manager (Sr CTM) for FSP EMEA, based in Saudi Arabia. This full-time role is accountable for achieving final clinical deliverables, specifically clean data from evaluable patients as outlined in study protocols, within the contractual timeframe. The position involves interpreting project data and making informed business decisions, supported by experienced team members or a line manager. This role operates within a division focused on Oncology/Cell therapy, working on projects of low to moderate complexity as part of a CTM team.

Key Responsibilities

• Manage all clinical operational and quality aspects of allocated studies, ensuring compliance with ICH GCP.
• Develop clinical tools, including Monitoring Plans, Monitoring Guidelines, and contribute to the Data Quality Plan.
• Contribute to the development of the Master Action Plan (MAP) for clinical-related documents.
• Ensure timely setup, organization, content, and quality of relevant sections of the Trial Master File (local and central).
• Implement and provide training on standardized clinical monitoring processes within studies and according to corporate policies.
• Ensure timely archiving of documents and study materials for the department.

Project Management and Coordination

• Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Work with the clinical team and other departments to meet project deliverables, leading team meetings to maintain timelines, resources, interactions, and quality.
• Monitor clinical activity timelines and metrics, provide status updates to the project manager, and review projects using tracking tools.
• Implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution.
• Continuously monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met.
• May coordinate all start-up activities and ensure timely ethics committee and regulatory submissions are addressed, ensuring essential document quality.
• May provide input into forecast estimates for clinical activities and manage clinical resources, assignments, and delegation of responsibilities.

Qualifications and Experience

• A minimum of 5 to 10 years of experience in clinical trial management.
• Demonstrated ability to manage clinical operational and quality aspects of studies.
• Proficiency in interpreting project data and making sound business decisions.
• Strong understanding of ICH GCP guidelines and clinical monitoring processes.
• Experience in collaborating with diverse teams and managing project timelines.

Work Environment and Travel

This role is primarily performed in an office environment, involving exposure to electrical office equipment. The position requires frequent driving to site locations and frequent travel, both domestic and international.

About Thermo Fisher Scientific

Thermo Fisher Scientific operates as a global team, committed to scientific excellence and innovation. The company fosters an environment where collaboration and professional development are integral to the daily experience, and where contributions are recognized within the scientific community.