Clinical Trial Operations Manager

3 weeks ago

Gurgaon, Haryana, India Lilly Full time
Job Description

We're seeking a highly skilled and experienced professional to join our team as a Clinical Trial Operations Manager. As a crucial member of our team, you will be responsible for providing clinical trial capabilities in support of clinical development. Your primary focus will be on ensuring that investigator sites meet the necessary requirements for enrolling study participants into clinical trials and supporting ongoing activities during site maintenance and close-out.

Key Responsibilities
  1. Site Activation and Management: Initiate investigator site activities in collaboration with Asia-Pacific Trial Capabilities Centre personnel, including monitoring of clinical trial regulations and requirements, providing consultation for effective communication with Competent Authority (CA) and relevant parties in addressing any validation questions on the clinical trial dossiers and resolving any barriers to approval.
  2. Lead and Participate global Clinical system related projects
  3. Manage ERB/CA submission and site readiness activities involving distribute and collect hard-copy documents.
  4. Serve as the local point of contact for Trial Capabilities-related activities that have to be managed locally.
  5. Communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract
  6. Monitor investigator payments and any other financial transactions related to Trial Capabilities which include, but not limited to, vendor creation and management, country/site budget tracking, and payment-related issue resolution
  7. Identify, communicate, and resolve issues
  8. Ensure country specific regulatory and data privacy requirements are communicated to Asia Pacific Trial Capabilities personnel for incorporation into submission documents and any other documents/systems
  9. Evaluate and escalate issues to aligned management and quality as appropriate
  10. Coordinate the management and delivery of clinical trial material to ensure support of site initiation
  11. Populate internal systems to ensure accuracy of trial / site performance
  12. Populate Trial Master Files and libraries for future reference
Requirements
  1. Bachelor's degree preferably in a scientific or health-related field
  2. At least Four (4) years, previous clinical trial experience or relevant experience preferred to be knowledgeable in Indian Regulatory activities and requirements
  3. Understanding of the overall clinical development paradigm and the importance of efficient site activation
  4. Applied knowledge of project management processes and skills
  5. Appreciation of / experience in compliance-driven environment
  6. Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
  7. Effective communication, negotiation, and problem-solving skills
  8. Self-management and organizational skills
  9. Language Capabilities – English (read, write, conversation) and local language, as applicable

Lilly is an equal opportunities employer and welcomes applications from diverse candidates.

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