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Form of workAt 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:
Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients. We intend to curate a balanced pipeline of medicines, either internally or externally discovered, with the potential to treat cancer with dramatic effect. Loxo@Lilly was created in December 2019, combining the Lilly Oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo@Lilly is a global organization with team members in Louisville, Colorado; Indianapolis, Indiana; New York City, New York; San Diego, California; South San Francisco, California; Stamford, Connecticut; and Madrid, Spain.
This individual, in collaboration with the study team, and/or other operational leadership, contributes to the execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable standard operating procedures (SOPs)/work instructions (WIs). Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of Contract Research Organization (CRO) teams and other vendors.
Responsibilities:
Develop and continually improve Clinical Operations departmental infrastructure including development of SOPs, WIs, and best practices.
Provide operational input on development, management and maintenance of study deliverables [i.e., timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
Contribute to deliverables within study, drive to solutions across a multi-functional study team.
Anticipate and resolve key technical operational problems with multi-functional study team; evaluate and determine issues that require escalation.
Use performance metrics and quality indicators to assist with driving study execution.
Manage the monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
Support Health Authority inspections and audits as required.
Ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
Provide proactive identification of potential risks and development/implementation of actions to avoid or mitigate.
Develop and maintain collaborative relationships with internal and external partners/stakeholders including both vendors and investigational sites.
Collaborate with vendors and other study team members regarding study specific issues and follow through to resolution.
Assist in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials and assist in updating these study documents as needed. The Senior Associate may have opportunities to lead creation/updates/review of study documents, as agreed upon with Clinical Operations study team.
Participate in vendor specification development and management/oversight. Vendor oversight activities may include responsibility for specific tasks associated with oversight (i.e., review of monitoring visit reports generated by CRO, invoice approval) or may include opportunities to lead the overall management of a specific vendor (i.e., travel vendor, ECG vendor, imaging vendor), as agreed upon with Clinical Operations study team.
Management of TMF set-up, ongoing quality review, and final reconciliation.
In conjunction with Drug Supply Management, manage shipment and reconciliation of Investigational Product (IP) at study and site level as needed, i.e., for clinical pharmacology studies.
Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
Actively contribute during study meetings including presenting as a subject matter expert as well as generating and distributing study team agendas and meeting minutes.
Contribute to development / coordination of study training and study training materials for study team, investigative sites, and vendors.
Contribute to oversight of the required country regulatory activities (e.g., Clinical Trial Application) and country/site IRB/IEC submissions/approvals/notifications.
Assist with the collection of various study documents such as country/site insurance, clinical study report appendices, etc.
Assist with Investigator Meeting coordination and planning.
Basic Requirements/ Qualifications:
BA/BS Degree in a relevant discipline and 2-3+ years of experience in the clinical trial environment required (inclusive of site level or other relevant experience)
Additional Preferences:
Knowledge of ICH/GCP and regulatory guidelines/directives.
Knowledge of drug development process.
Analytical approach and ability to anticipate problems.
Effective communication and social skills, self-awareness, and motivation.
Ability to identify gaps and provide constructive feedback and solutions.
Ability to follow issues to resolution and escalate as appropriate.
Sound problem solving skills for complex issues.
Rudimentary understanding of management skills and drug development process.
Ability to multi-task effectively and prioritize assignments from multiple sources.
Excellent organizational skills.
Willingness to proactively share information, ideas, input, and/or expertise to effectively collaborate with various team members and demonstrates propensity for delivering high quality outcomes.
Ability to respond flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
Ability to be enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies.
Strong communication skills, written and oral English proficiency.
Proficiency in Microsoft Office suite and applications.
Knowledge of study tools that can be effectively leveraged to deliver objectives (e.g., including electronic system skills such as CTMS/ EDC/ IRT/ eTMF.
For oncology studies: Oncology and/or hematology experience preferred
For clinical pharmacology focused roles: Clinical pharmacology/healthy volunteer experience preferred.
Additional Information:
The physical demands of this job are consistent with light office duties.
Up to 25% travel may be required.
This position’s work environment is in an office
*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Lilly currently anticipates that the base salary for this position could range from between $76,000 to $112,200 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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