Amendment Implementation Specialist

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Executes amendment activities for assigned projects, ensuring that deliverables align with customer expectations.

• Aids in the development of the amendment implementation strategy at both country and site levels.

• Assists in comprehending the scope, classification, and timelines of the amendments.

• Collaborates with project teams to plan amendments effectively.

• Engages in discussions regarding financial coverage for amendments with the Project Lead.

• Monitors amendment-related actions and facilitates updates within the relevant system(s).

• Organizes and leads progress check calls with project teams.

• Updates the Principal Investigator Amendment Notification and Amendment Implementation Letters.

• Prepares and circulates the Amendment Progress Report and other related study reports.

• Adjusts forecasting and actuals for amendment-related units in accordance with Clarity's monthly deadlines.

• Notifies project team members upon the completion of amendment activities.

• Assists in identifying risks and planning contingencies related to amendments.

⛳️ Requirements

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

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary for the role.

• Awareness of the audit/inspection processes, including relevant rules and guidance documents.

• In-depth knowledge of a specific application, system, or process.

• Strong organizational skills coupled with meticulous attention to detail.

• Capability to effectively analyze project-specific data/systems to ensure precision and efficiency.

• Proficient analytical skills.

• A strong focus on customer satisfaction.

• Adaptability to reprioritize workload in response to changing project timelines.

• Familiarity with ICH GCP guidelines.

• Proficient in English (both verbal and written).

• Competent computer skills, with proficiency in MS Office (Word, Excel, PowerPoint).

• Ability to work collaboratively in a team or independently as needed.

• Strong negotiation abilities.

• A comprehensive understanding and appreciation of clinical research and development.

🏝️ Benefits

• Reasonable accommodation for individuals with disabilities.

• Equal Opportunity Employer.