Trial Capabilities Manager

1 month ago

gurugram, India Lilly Full time

We’re looking for people who are determined to make life better for people around the world.

The Trial Capabilities Manager provides clinical trial capabilities in support of clinical development. The Manager is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials and support ongoing activities during site maintenance and close-out. The Manager provides local support to complement the centralized activities performed by Asia Pacific Trial Capabilities Centre (AP TCC) to ensure compliance with local requirements/needs. The Manager will ensure inspection readiness at all times following GCP; any local/regional requirements and Lilly operating procedures and through a complete, accurate and readily available Trial Master File (TMF) as per defined TMF document ownership. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

Clinical Trial Responsibilities

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. Lead and Participate global Clinical system related projects Manage ERB/CA submission and site readiness activities involving distribute and collect hard-copy documents. Serve as the local point of contact for Trial Capabilities-related activities that have to be managed locally. The activities include, but not limited to meeting with site, ERB and CA for trial-related discussion; communicate with Site Engagement and external party / clinical research organization to enable active collaboration during site activation, maintenance and close-out Communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract 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  Identify, communicate, and resolve issues 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 Escalate issues to aligned management and quality as appropriate Coordinate the management and delivery of clinical trial material to ensure support of site initiation 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 guidances, Lilly Medical policies and procedures, and good clinical practices (GCP)

Minimum Qualification Requirement:

Bachelor’s degree preferably in a scientific or health related field At least Four (4) years, previous clinical trial experience or relevant experience preferred to be knowledgeable in Indian Regulatory activities and requirements 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 communication, negotiation, and problem solving skills Self-management and organizational skills Language Capabilities – English (read, write, conversation) and local language, as applicable

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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