Job Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We\xe2\x80\x99re looking for people who are determined to make life better for people around the world.

The Trial Capabilities (TC) Senior Associate provides clinical trial capabilities in support of clinical development. The Sr 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 close-out. The Sr Associate is responsible for obtaining clinical trial authorizations and ethical approvals, execution of the budget and contract, records management and site training. The Sr Associate will ensure inspection readiness at all time following GCP and any local/regional requirements. In addition, the Sr Associate is expected to manage high priority and complex clinical trials or trials involving high number of investigator sites; Capable of providing submission strategy & status for the assigned studies. Provides coaching and technical support to other Associates/Specialists in managing the site-related TC activities for a study.

Primary 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\xe2\x80\x99s ethics review board (ERB) and competent authority (CA), 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, Lilly functions, clinical research organization (CRO) to enable start-up and maintain an active collaboration with sites during maintenance and close-out.

Act as subject matter expert on Trial Capabilities topics and provide oversight, coaching and technical support to Associates in managing high priority and complex clinical trials.

Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems.

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.

Provide feedback and shared learning for continuous improvement.

Strategic use of internal clinical trial systems (e.g. Vault Clinical, Shared Investigator Platform, etc ) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements.

Ensure complete, accurate and timely documentation & filing in Trial Master File (eTMF).

Able to determine & execute the submission & site activation strategies according to the priority set by the Global team.

Able to influence other function/CRO on activation priorities locally for high prioritise assets and to ensure relevant stakeholders delivering supplies & IP & Study Material supplies as prioritised.

Able to identify gaps, propose and drive continuous improvement effort on TC processes & usability of applications/systems.

Able to drive effective team interactions among APAC TC team members.

Able to influence effective working relationships with Lilly internal partners.

Minimum Qualification Requirements

Bachelor\xe2\x80\x99s degree preferably in a scientific or health related field

Three (3) years 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 compliance-driven environment

Effective communication, negotiation, and problem-solving skills

Self-management and organizational skills

Language capabilities \xe2\x80\x93 English (read, write, conversation)

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively \xe2\x80\x9cLilly\xe2\x80\x9d) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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