FSP Local CTM

About the Role

Thermo Fisher Scientific, Inc. is seeking a Clinical Trial Manager (CTM) to manage studies locally in Saudi Arabia for one of its clients. This full-time position requires 5-10 years of experience and focuses on achieving clinical deliverables within specified timelines and quality standards.

Role Overview

The Clinical Trial Manager is responsible for the final clinical deliverable, typically clean data from evaluable patients as outlined in the study protocol, within the contractual timeframe. The CTM interprets project data to make informed business decisions, ensuring all clinical deliverables meet customer expectations regarding time, quality, and cost. This role also involves maintaining profitability by managing clinical activity within contract scope through efficient team oversight. The position involves working on projects of low to moderate complexity as part of a team of CTMs.

Key Responsibilities

• Manage clinical operational and quality aspects of allocated studies, adhering to ICH GCP, for projects of low to moderate complexity. May assume Clinical Study Manager (CSM) responsibilities for smaller or less complex projects.
• Develop clinical tools such as Monitoring Plans and Guidelines, and contribute to the Master Action Plan for clinical documents. Ensure timely setup, organization, content, and quality of relevant sections of the Trial Master File (local and central).
• Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Communicate regularly with the clinical team, leading meetings to maintain timelines, resources, interactions, and quality. Implement and train on standardized clinical monitoring processes within the study and according to corporate policies.
• Ensure achievement of clinical deliverables by monitoring timelines and metrics, providing status updates, reviewing projects with tracking tools, implementing recovery actions, and managing CRF collection and query resolution.
• Continuously monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met.
• Communicate with study sites regarding protocol, patient participation, case report form completion, and other study-related issues.
• Coordinate all start-up activities and ensure timely ethics committee and regulatory submissions are addressed, verifying essential document quality meets Regulatory Compliance Review expectations.
• Provide input into forecast estimates for clinical activities and manage clinical resources, including assignment, delegation of responsibilities, and identification of additional resource requirements.

Required Experience

• 5-10 years of experience in clinical trial management or a related field.

Working Conditions

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

Company Culture

Joining Thermo Fisher Scientific means becoming part of a global team that values innovation and scientific excellence. The company fosters an environment where collaboration and professional development are integral to the daily experience, and individual contributions are recognized.