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- Initiate investigator activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for an investigator's ERB and Competent Authority (CA) (where applicable), communicate and negotiate budgets with investigator personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure investigator (and/or delegate) compliance to required training, track and ensure investigator (and/or delegate) access to required clinical systems and supplies, and effectively drive timelines aligned with company priorities
- Communicate directly with investigators (and/or delegates) to enable start-up and maintain an active collaboration during maintenance and close-out
- Identify, communicate, and resolve issues
- Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
- Leverage previous investigator / review board engagements to efficiently drive new work
- Populate internal systems to ensure accuracy of trial / investigator performance
- Understand and comply with procurement, legal and financial requirements and procedures
- Populate Trial Master Files and libraries for future reference
- Provide feedback and shared learning for continuous improvement
- Leverage trial prioritization
- Anticipate and monitor dynamically changing priorities
- Bachelor's degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
- Understanding of ICH GCP requirements paradigm and the importance of efficient site activation
- Applied knowledge of project management processes and skills
- Appreciation of / experience in compliance-driven environment
- Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
- Effective communication, negotiation, and problem solving skills
- Self-management and organizational skills
- Language Capabilities: advanced English
Trial Capabilities Associate - São Paulo, Brasil - Lilly
Descrição
We're looking for people who are determined to make life better for people around the world.
Principais desafios:
Requisitos:
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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