FSP Local CTM Saudi Arabia

Thermo Fisher Scientific Inc; Medina; On-site; SAR 350,000 - 650,000; Full time

Job summary

Thermo Fisher Scientific Inc. is seeking a Clinical Trial Manager to lead local Saudi studies with focus on delivering clean data and adhering to contractually defined timelines, quality, and cost targets.

You will oversee clinical operations, develop monitoring tools, and coordinate with cross-functional teams to ensure high standards and on-time delivery. Ideal candidates hold a Bachelor's degree with 5+ years of experience in clinical monitoring, budgeting, and regulatory compliance, and are

Qualifications

• Bachelor's degree or equivalent and relevant formal academic/ vocational qualification (5+ years experience typical).
• Strong leadership, planning, and organizational skills for workload prioritization.
• Excellent interpersonal and problem-solving abilities in a multicultural matrix context.
• Good judgment, communication skills in English, and budgeting/fiscal awareness.

Responsibilities

• Manage all clinical operational and quality aspects of allocated studies of low to moderate complexity in compliance with ICH GCP.
• Develop clinical tools such as Monitoring Plan and Monitoring Guidelines with Data Quality Plan.
• Contribute to the Master Action Plan for providing clinical documents.
• Ensure timely setup, organization, content and quality of Trial Master File sections.
• Collaborate with the project manager to prepare and present at client meetings.

Skills

Leadership

Planning & Organizing

Interpersonal skills

Problem solving

Communication

Budgeting

Financial management

Attention to detail

Regulatory knowledge

Education

Bachelor's degree or equivalent

Tools

Outlook

Excel

Word

Job description

Job Description

Join Us as a Clinical Trial Manager managing studies locally in Saudi Arabia for one of our clients. Make an Impact at the Forefront of Innovation. 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 Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer s time quality cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.

What You ll Do

• Manage all clinical operational and quality aspects of allocated studies of low to moderate complexity in compliance with ICH GCP. In accordance to project specific requirements may assume Clinical Study Manager CSM responsibilities on small and or less complex projects.
• Develop clinical tools e g Monitoring Plan 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.
• May participate in the design and development of CRFs CRF guidelines patient informed consent templates and other protocol specific documents as required.
• Collaborate with the project manager to prepare organize and present at client meetings including bid defense and hand-off meetings.
• Collaborate with the clinical team and other departments as needed to meet deliverables of the project.
• Regularly communicate with the team and lead team meetings to ensure that timelines resources interactions and quality are maintained.
• Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies.
• Responsible for the timely archiving of documents and study materials for the department.
• Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics providing status updates to the project manager regularly reviewing projects using tracking and management tools implementing recovery actions reviewing monitoring visit reports and managing CRF collection and query resolution.
• Continuously monitor or co-monitors 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.
• May communicate with study sites regarding issues such as protocol patient participation case report form completion and other study-related issues.
• May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions if appropriate are addressed.
• Ensure that essential document quality meets the expectation of Regulatory Compliance Review Review and follows up on all questions raised by the ethics committees.
• May provide input into preparation of forecast estimates for clinical activities.
• Responsible for clinical resource management assignment delegation of clinical responsibilities and identification of additional resource requirements.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
• Good planning and organizational skills to enable effective prioritization of workload.
• Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization.
• Capable of working effectively in a changing environment with complex/ambiguous situations.
• Familiarity with the practices, processes, and requirements of clinical monitoring.
• Good judgment and decision making skills.
• Effective oral and written communication skills, including English language proficiency.
• Capable of evaluating workload against project budget and adjusting resources accordingly.
• Sound financial acument and knowledge of budgeting, forecasting and fiscal management.
• Strong attention to detail.
• Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.