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Trial Capabilities Senior Associate

52224
Trial Capabilities Senior Associate
Sydney
New South Wales
Asia/Pacific
Australia
Local
Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.
Our local AU website is available at https://www.lilly.com.au/en/index.aspx
The Trial Capabilities Senior Associate provides clinical trial capabilities in support of clinical development. The Senior Associate is accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and close-out. The Senior Associate is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, and activities related to clinical finance, records management and site training. The Senior Associate will ensure inspection readiness at all times.

Roles and Responsibilities:
  • 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 , 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 Site Engagement and external party / clinical research organization to enable active collaboration during site activation, maintenance and close-out
  • Manage investigator payments and any other financial transactions related to Trial Capabilities
  • 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 site / review board engagements to efficiently drive new work
  • 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
  • Understand and comply with procurements, legal and financial requirements and procedures
  • Understand, comply, and reinforce local regulations and guidances, Lilly Medical policies and procedures, and good clinical practices (GCP)

52224BR
  • Bachelor’s degree preferably in a scientific or health related field
  • At least 3 years combined experience in clinical trial, clinical project management and site activation experience
  • 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 compliance-driven environment
  • Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
  • Effective negotiation and problem solving skills
  • Self-management and organizational skills
  • Effective communication and written skills