FSP Local CTM Saudi Arabia

Role Overview

FSP Local Clinical Trial Manager position with Thermo Fisher Scientific, managing clinical studies locally in Saudi Arabia.

Role Purpose

The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The role involves interpreting data on project issues, making sound business decisions with support from experienced team members or line manager, and ensuring all clinical deliverables meet the customer's time, quality, and cost expectations while maintaining profitability through efficient management of the clinical team.

Key Responsibilities

Clinical Operations & Compliance

• Manage all clinical operational and quality aspects of allocated studies of low to moderate complexity in compliance with ICH GCP.
• Assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects as required by project-specific requirements.
• Continuously monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met.

Clinical Documentation & Tools

• Develop clinical tools including Monitoring Plan and Monitoring Guidelines in conjunction with the Data Quality Plan.
• Contribute to the development of the Master Action Plan (MAP) for providing clinical-related documents.
• Ensure timely set up, organization, content, and quality of the relevant sections of the Trial Master File (local and central).
• Participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents as required.
• Ensure timely archiving of documents and study materials for the department.

Stakeholder & Team Management

• Collaborate with the clinical team and other departments as needed to meet project deliverables.
• Regularly communicate with the team and lead team meetings to ensure timelines, resources, interactions, and quality are maintained.
• Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Communicate with study sites regarding protocol, patient participation, case report form completion, and other study-related issues.
• Provide input into preparation of forecast estimates for clinical activities.

Process Implementation & Training

• Implement and provide training on standardized clinical monitoring processes within the study and according to corporate standard policies.

Timeline & Deliverable Management

• Ensure achievement of the final clinical deliverable within the contractual time period by preparing and monitoring clinical activity timelines and metrics.
• Provide status updates to the project manager.
• Regularly review projects using tracking and management tools.
• Implement recovery actions as needed.
• Review monitoring visit reports.
• Manage CRF collection and query resolution.

Regulatory & Ethics Coordination

• Coordinate all start-up activities and ensure timely ethics committee and regulatory submissions (if appropriate) are addressed.
• Ensure essential document quality meets the expectation of Regulatory Compliance Review.
• Review and follow up on all questions raised by ethics committees.

Financial & Resource Management

• Maintain profitability by ensuring clinical activity is conducted within contract scope.
• In smaller regions, conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• Manage clinical resource assignment, delegation of clinical responsibilities, and identification of additional resource requirements.
• Evaluate workload against project budget and adjust resources accordingly.

Qualifications & Experience

• Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
• Previous experience providing knowledge, skills, and abilities to perform the job, comparable to 5 or more years.
• In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient.

Skills & Competencies

• Leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
• Planning and organizational skills to enable effective prioritization of workload.
• Interpersonal and problem-solving skills to enable working in a multicultural matrix organization.
• Ability to work effectively in a changing environment with complex and ambiguous situations.
• Familiarity with the practices, processes, and requirements of clinical monitoring.
• Sound judgment and decision-making skills.
• Oral and written communication skills, including English language proficiency.
• Computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, and Word.
• Sound financial acumen and knowledge of budgeting, forecasting, and fiscal management.
• Strong attention to detail.
• Solid understanding of relevant regulations including ICH/GCP and FDA guidelines.

Additional Information

Work Schedule

• Standard Monday through Friday.

Work Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations.
• Frequently travels both domestic and international.