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Clinical Trial Associate/Manager – Audiology

Location: Indianapolis, Indiana, United States of America

Category: Research & Development

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

Organization Overview:

Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company focused on developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals who live with disabling hearing loss worldwide.

Responsibilities:

The Clinical Trial Specialist, Clinical Operations, is responsible for supporting clinical study/trial execution including, but not limited to, participation in the preparation of study/trial related materials, management of study/trial sites and vendors, maintenance of the Trial Master File (TMF), and management of deliverables for clinical study/trials.

Manage clinical study/trial activities from start-up through database lock, ensuring adherence to protocol, ICH GCP, regulatory guidelines, and relevant SOPs
Coordinate and ensure completion of study/trial start up activities, e.g., collection of site documents and review of study/trial-specific documents provided by CRO
Support the creation and distribution of study/trial documents and plans; participate in Case Report Form design and User Acceptance Testing for electronic Case Report Forms and other platforms
TMF maintenance and health tracking, including filing and QC of relevant documents according to study/trial specific TMF plan, ICH GCP, and SOPs
Track and monitor program related activities, e.g., enrollment, monitoring frequency, and invoicing
Facilitate and track the resolution of any study/trial site issues, e.g., Investigational Medicinal Product/Investigational Medical Device & other supplies, invoicing/payment
Review monitoring reports, protocol deviations, and data listings to ensure reliable quality data are delivered
Establish and maintain effective relationships with clinical sites and vendors

Basic Qualifications:

Bachelor’s and/or Master’s degree; degree in health or biologic science is preferred.

3+ years of clinical research experience

Additional Skills/Preferences:

Excellent listening and communication skills, as well as organizational skills
Strong knowledge of ICH Good Clinical Practice principles
Proficient with TMF maintenance
Proven ability to work effectively in a cross-functional team
Previous experience with gene therapy, rare disease, and/or audiology preferred
Previous experience with regulatory authority inspections preferred

Additional Information:

Ability to travel up to 20% of the time.

Position may be office based (Boston, MA) or remote; however, employee may be asked to go into the office once a quarter.
Lilly currently anticipates that the base salary for this position could range from between $63,000 to $138,600 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees

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 ( 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 is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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