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Amendment Implementation Specialist - Job Opportunity at Thermo Fisher Scientific

Remote, India
Full-time
Mid-level
Posted: May 17, 2025
Remote
USD 45,000 - 65,000 annually based on Indian market rates for clinical research specialists

Benefits

Global industry exposure and cross-cultural work environment
Second shift schedule offering work-life balance
Professional development in clinical research industry
Exposure to global pharmaceutical projects

Key Responsibilities

Lead amendment implementation strategies across global clinical trials with direct impact on study outcomes
Coordinate with cross-functional teams to ensure regulatory compliance and timely amendment execution
Manage financial assessments and resource allocation for amendment implementation
Drive risk assessment and mitigation strategies for amendment processes
Facilitate global communication and progress tracking across project teams
Ensure regulatory compliance and documentation accuracy for trial amendments

Requirements

Education

Bachelor's degree or equivalent and relevant formal academic/vocational qualification

Experience

Previous relevant experience required (not specifically quantified)

Required Skills

Expert knowledge of clinical trial applications and systems Advanced English proficiency Strong organizational and analytical skills ICH GCP knowledge MS Office proficiency Cross-cultural communication abilities Project management expertise Risk assessment capabilities
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Industry Trends

Clinical trial complexity is increasing with the rise of adaptive trial designs and remote monitoring capabilities Growing demand for specialists who can handle global regulatory requirements in clinical research Increasing focus on risk-based approaches in clinical trial management Digital transformation in clinical trials creating need for tech-savvy amendment specialists

Role Significance

Typically works within a global clinical operations team of 10-15 members
Mid-level specialist role with significant responsibility for ensuring trial integrity and compliance

Key Projects

Global multi-center clinical trial amendments Regulatory compliance implementations Process optimization initiatives Cross-functional team coordination projects

Success Factors

Strong understanding of global regulatory environments and ability to navigate cross-cultural challenges Excellent project management skills with ability to handle multiple concurrent amendments Detail-oriented approach combined with strategic thinking for risk assessment Strong stakeholder management abilities across global teams

Market Demand

High demand position due to increasing clinical trial complexity and regulatory requirements, particularly in emerging markets like India

Important Skills

Critical Skills

Regulatory knowledge and GCP compliance expertise are essential due to increasing trial complexity Project management and stakeholder coordination capabilities are crucial for successful amendment implementation Risk assessment and mitigation skills are vital for ensuring trial integrity

Beneficial Skills

Experience with electronic trial management systems Understanding of multiple therapeutic areas Knowledge of global regulatory frameworks Change management expertise

Unique Aspects

Remote work opportunity in a global clinical research environment
Exposure to cutting-edge clinical trial methodologies
Opportunity to work with diverse therapeutic areas and global teams
Career growth potential in a rapidly expanding sector

Career Growth

2-3 years in role before advancement opportunities, depending on performance and project complexity handled

Potential Next Roles

Senior Clinical Trial Manager Regulatory Affairs Manager Clinical Operations Lead Project Management Office (PMO) Lead

Company Overview

Thermo Fisher Scientific

Thermo Fisher Scientific is a global leader in serving science with over $40 billion in annual revenue and a significant presence in clinical research services

Industry leader in scientific research and clinical trial services with strong market position
Major presence in India's clinical research sector with significant growth opportunities
Professional environment with emphasis on scientific excellence and global collaboration
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