Trial Capabilities Senior Associate For Asia Pacific Region

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Purpose

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 enroll study participants into clinical trials and support ongoing activities during site maintenance and closeout.

The Senior Associate is responsible for obtaining clinical trial authorizations and ethics approvals, execution of the budget and contract, and activities related to clinical finance, record management and site training. The country-based Senior Associate will provide local support to complement the centralized activities performed by Asia Pacific Trial Capabilities Centre to ensure compliance with local requirements/needs. The Battle of the Senior Associate will ensure inspection readiness at all times following GCP; 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.

Primary Responsibilities

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

• Clinical Trial 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 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 contracts, 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).

For Trial Capabilities Senior Associate Role

In addition to the above responsibilities, the Senior Associate should also be the ultimate responsible person in managing high priority (Game Changer, Potential Game Changer) and complex clinical trials or trials involving

high number of investigator sites, and to provide oversight of the submission status for the assigned studies and provide coaching and technical support to Associates/Specialists in managing the site-related trial capabilities

activities for a study.

Specific to Clinical Trial Payment: Participate in the evaluation of new payment systems, provide quality oversight on payment-related process to ensure compliance and effective communication with CDDA functions, clinical

research organization and sites in resolving payment-related queries. Act as Subject Matter Expert (SME) to Associates/Specialists in resolving clinical trial payment related issues and identifying process improvement opportunities.

Minimum Qualification Requirements

Bachelor's degree preferably in a scientific or health related field

At least three (3) years for Senior Associate. Previous clinical

Other Information/Additional Preferences

trial 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 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 is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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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