Trial Capabilities Associate (GMF-466)

Trial Capabilities Associate (GMF-466)

29 Jul
Eli Lilly and Company
West Ryde

29 Jul

Eli Lilly and Company

West Ryde

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 39,000 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’re looking for people who are determined to make life better for people around the world.

The Trial Capabilities Associate provides clinical trial capabilities in support of clinical development.

The 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 associate is responsible for obtaining clinical trial authorizations

and ethical approvals, execution of the budget and contract, and activities related to clincial finance, records management and site training. The associate will ensure inspection readiness through a complete, accurate and readily available Trial Master File. 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, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), 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 which include, but not limited to, vendor creation and management, PO creation and maintenance, payment activities, country/site budget tracking, and payment-related issue resolution

- 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

- 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)

Specific To Trial Capabilities Senior Associate Role

- In addition to the above responsibilities, the Senior Associate should also be the ultimate responsible person in managing 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 in managing the site-related trial capabilities activities for a study.

Minimum Qualification Requirements

- Bachelor’s degree preferably in a scientific or health related field

- At least one (1) year for Associate, and three (3) years for Senior Associate, previous clinical 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

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) 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 ( [email protected] ) 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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