Assistant -Trial Capabilities
Full time @Eli Lilly in Pharmaceuticals Shortlist Email JobJob Detail
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Job ID 1844
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Career Level Others
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Experience 2 Years
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Qualifications Associate
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 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.
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. #WeAreLilly
The Trial Capabilities Assistant role provides technical support to the clinical trial capabilities team in support of clinical development. The assistant is responsible for activities related to investigator sites readiness, maintenance and close out. The assistant will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional country specific 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.
- Initiate investigator site activities, including collection and submission of regulatory documents.
- Track and ensure site compliance to effectively drive timelines aligned with company priorities
- Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out
- Support TPO and investigator payments as appropriate
- Manage site account requests
- Invoice query resolutions
- Identify, communicate, and resolve issues
- Accountable for accurate and complete data entry of clinical trial information into various clinical trial systems to allow tracking, performance metrics reporting and to meet regulatory compliance requirements.
- Ensure appropriate archiving of documets to meet Lilly record retention polcies and regulatory requirements.
- Ensure inspection readiness through a complete, accurate and readily available Trial Master File
Minimum Qualification Requirements:
- Associate’s Degree or HS diploma/GED with 2 years of equivalent experience preferably in a scientific or health related discipline
- Qualified candidates must be legally authorized to be employed in the U.S. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Additional Preferences:
- Clinical trial experience a plus
- Applied knowledge of project management processes and skills
- Appreciation of / experience in compliance-driven environment
- Ability to learn and comply with regulatory requirements and internal policies.
- Effective communication, team work and problem solving skills
- Very good attention to details and accuracy
- Self-management and organizational skills
- Excellent computer skills
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.
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.