Clinical Job at Thermo Fisher – Clinical Operations Jobs | Apply
Thermo Fisher is hiring for a Clinical Job at Thermo Fisher, offering an exciting opportunity for professionals in Clinical Operations Jobs. This fully remote position in India focuses on Trial Master File (TMF) oversight, process optimization, and inspection readiness, offering an opportunity to contribute to innovative clinical research projects. Candidates with expertise in clinical documentation management and pharmaceutical operations will thrive in this dynamic role.
- Job Position: Manager Clinical Operations – TMF
- Job ID: R-01327453
About the Company:
Thermo Fisher Scientific is a global leader in serving science, delivering innovative solutions for clinical research, diagnostics, and laboratory services. The company is dedicated to advancing healthcare through state-of-the-art technology and process excellence, making it a top choice for professionals seeking Clinical Operations Jobs.
Qualifications:
- Bachelor’s or Master’s degree in Medicine or paramedical science.
- Sound knowledge of the pharmaceutical/healthcare and digital/IT industry, including GxP regulations, ICH-GCP, FDA, EMA, and ALCOA principles.
- Experience in clinical development/operations with a focus on TMF/documentation management, ideal for Clinical Operations Jobs.
- Skilled in business/process consulting, change management, and stakeholder engagement.
- Knowledge of implementing processes and systems in a global GCP setting.
- Strong affinity for data and digitalization with the ability to generate insights.
- Excellent communication and presentation skills.
- Proficient in process documentation and IT systems such as Veeva Vault.
- Experience managing clinical trial documentation risks.
- Fluent in English (written and verbal).
Job Description:
This Clinical Job at Thermo Fisher involves developing and optimizing processes to enhance the TMF Oversight process. Key responsibilities include designing a TMF Study Health Dashboard, establishing inspection readiness milestones, and supporting improvements in knowledge management. The role ensures efficient oversight, effective study health management, and data-driven decision-making.
Key Responsibilities:
- Develop a process framework integrating recurring milestone functionality into TMF Oversight.
- Design a TMF Study Health Dashboard for improved visibility and proactive management.
- Establish inspection readiness milestone tasks and user enablement activities.
- Enhance TMF Oversight knowledge management for better accessibility and usability.
- Refine TMF health analysis outcomes and metrics to support decision-making.
- Optimize system User Tasks for alignment with oversight objectives and efficiency.
