FSP Local CTM

About the Role

Thermo Fisher Scientific is seeking a FSP Local Clinical Trial Manager (CTM) to manage clinical studies locally in Saudi Arabia for one of its clients. This full-time role involves overseeing clinical deliverables for projects of low to moderate complexity, ensuring adherence to contractual obligations and quality standards.

Role Purpose and Scope

The Clinical Trial Manager is responsible for achieving the final clinical deliverable, typically clean data from evaluable patients as defined in the study protocol, within the timeframe specified in the customer contract. This position involves interpreting data on project issues, making informed business decisions with support, and ensuring all clinical deliverables meet customer expectations regarding time, quality, and cost. The CTM maintains profitability by ensuring clinical activity is conducted within the contract scope through efficient management of the clinical team.

Key Responsibilities

• Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. May assume Clinical Study Manager (CSM) responsibilities on smaller or less complex projects.
• Develop clinical tools such as Monitoring Plans and Monitoring Guidelines in conjunction with the Data Quality Plan. Contribute to 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). May participate in the design of CRFs, CRF guidelines, and patient informed consent templates.
• 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 and lead team meetings to ensure timelines, resources, interactions, and quality are maintained.
• Implement and train on standardized clinical monitoring processes within the study and according to corporate standard policies.
• Ensure timely archiving of documents and study materials for the department.
• Monitor clinical activity timelines and metrics, provide status updates to the project manager, 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. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• Communicate with study sites regarding issues such as protocol, patient participation, and case report form completion.
• Coordinate all start-up activities and ensure timely ethics committee and regulatory submissions are addressed. Review and follow up on questions raised by ethics committees.
• Provide input into the preparation of forecast estimates for clinical activities. Manage clinical resources, assign and delegate clinical responsibilities, and identify additional resource requirements.

Experience Requirements

• Candidates should possess 5-10 years of relevant experience in clinical trial management.

Work Environment

This role operates primarily in an office environment with exposure to standard electrical office equipment. Frequent driving to site locations and both domestic and international travel are required.