Amendment Implementation Specialist

Thermo Fisher Scientific; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking an Amendment Implementation Specialist to ensure project deliverables meet customer expectations. This role involves supporting amendment strategies at various levels, collaborating with project teams, and managing amendment actions. The ideal candidate will possess strong organizational and analytical skills, along with a customer-focused approach. Join a dynamic team committed to excellence in clinical research, where your contributions will directly impact project success and client satisfaction. This is an exciting opportunity to thrive in a collaborative environment and advance your career in clinical development.

Qualifications

• Bachelor's degree or equivalent with relevant qualifications.
• Previous experience demonstrating necessary knowledge and skills.

Responsibilities

• Support amendment implementation strategies at various levels.
• Collaborate on amendment planning with project teams.
• Track amendment actions and update relevant systems.

Skills

Organizational Skills

Analytical Skills

Communication Skills

Collaboration Skills

Customer Focus

Risk Identification

Flexibility

Education

Bachelor's Degree or Equivalent

Tools

MS Office

Clinical Trial Database Systems

Job description

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Office

Job Description

Amendment Implementation Specialist

Summary: Responsible for executing amendment activities within assigned projects, ensuring deliverables meet customer expectations and contractual milestones through accurate projections, report updates, and ongoing risk assessments.

Key Responsibilities:

1. Support amendment implementation strategies at country, site, regional, or global levels.
2. Understand amendment scope, classification, and timelines.
3. Assist with requests from country resources in Clarity.
4. Collaborate on amendment planning with project teams.
5. Discuss financial coverage for amendments with the Project Lead.
6. Track amendment actions and update relevant systems.
7. Schedule and lead progress check calls with project teams.
8. Update Principal Investigator Amendment Notifications and Implementation Letters.
9. Liaise with Regulatory Affairs Leads to assess submission requirements and timelines.
10. Prepare and distribute the Amendment Progress Report and other study reports, including deadlines for feedback.
11. Update forecast and actuals for amendments in Clarity monthly.
12. Notify team members upon completion of amendment activities.
13. Support risk identification and contingency planning related to amendments.
14. Define roles and responsibilities within project teams.
15. Request access to study-related systems.

Education & Experience:

• Bachelor's degree or equivalent with relevant qualifications.
• Previous experience demonstrating the necessary knowledge, skills, and abilities.

Knowledge, Skills, and Abilities:

• Awareness of audit/inspection processes and relevant guidelines.
• Proficiency with applications, systems, or processes related to the role.
• Strong organizational skills and attention to detail.
• Ability to analyze project data for accuracy and efficiency.
• Excellent analytical skills and understanding of data and tables.
• Customer-focused approach.
• Flexibility to adjust priorities as needed.
• Knowledge of ICH GCP, SOPs, and clinical trial lifecycle.
• Proficiency in English (verbal & written).
• Competence in MS Office and clinical trial database systems.
• Strong collaboration, communication, and negotiation skills.
• Ability to work independently and in teams.
• Understanding of cross-functional project management principles.
• Ability to identify and address contractual risks.
• Cross-cultural awareness and adaptability.
• Understanding of clinical research, medical terminology, and therapeutic areas.
• Leadership and coordination skills for cross-functional teams.
• Knowledge of clinical development guidelines and directives.