[Work From Home] Thermo Fisher Scientific Hiring In Clinical Trials

The Trial Management Specialist III manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. The role involves:

• Project Management: Assumes Clinical Study Manager (CSM) responsibilities on small and/or less complex projects as needed.
• Development of Clinical Tools: Develops clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical-related documents.
• Documentation: Ensures timely set-up, organization, content, and quality of the relevant sections of the Trial Master File (local and central). Participates in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents as required.
• Team Collaboration: Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. Communicates regularly with the clinical team and other departments to meet project deliverables.
• Standardization and Training: Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Ensures timely archiving of documents and study materials.
• Performance Monitoring: Ensures achievement of the final clinical deliverable within the contractual time period by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, and implementing recovery actions as needed.
• Field Visits: In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.

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