Initiate investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ethics review board (ERB) and competent authority (CA) (where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities.
Communicate with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out.
Communicate with Clinical Design, Delivery and Analytics (CDDA) functions and external party / clinical research organization to enable active collaboration during site activation, maintenance, and close-out.
Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.
Identify, communicate, and resolve issues. Escalate issues to aligned management and quality as appropriate.
Coordinate the management and delivery of clinical trial material to ensure support of site initiation.
Coordinate translation process for clinical trial documents and oversight of translation quality.
Populate internal systems to ensure accuracy of trial / site performance.
Populate Trial Master Files and libraries for future reference.
Provide feedback and shared learning for continuous improvement.
Anticipate and monitor dynamically changing priorities.
Understand and comply with procurements, legal and financial requirements, and procedures.
Understand, comply, and reinforce local regulations and guidance, Lilly Medical policies and procedures, and Good Clinical Practice (GCP).
Qualifications
Bachelor’s degree preferably in a scientific or health related field.
At least one year clinical research experience or relevant experience preferred.
Understanding of the overall clinical development paradigm and the importance of efficient site activation.
Applied knowledge of project management processes and skills.
Appreciation of / experience in fast moving and compliance-driven environment.
Ability to learn and comply with financial and legal guidelines and policies (e.g. budget and contract).
Effective communication, negotiation, and problem-solving skills.
Self-management and good organizational skills. Able to multitask.
Agile and adaptable fast to changes with positive mindset.
Language Capabilities – English (read, write, conversation) and local language, as applicable.
Computer literacy – familiar with MS Words and Excel.
