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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Summary:
This individual will manage one (or more) clinical studies including leading the planning, organization, and coordination of all operational aspects of the clinical study from protocol development through database lock / study closure; 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); Provide operational leadership on cross-functional study team(s) and 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 leadership, coaching and mentoring, on development, management and maintenance of study deliverables (i.e., timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders.
• Lead and manage the execution of clinical trials, drive to solutions and facilitate decision making across a multi-functional study team.
• Anticipate and resolve complex and key technical, operational or business problems with multi-functional study team; evaluate and determine issues that require escalation.
• Proactively identify potential risks and lead the development/implementation of actions to avoid or mitigate; identify points for escalation.
• Support Health Authority inspections and audits as required, including driving inspection/audit readiness through life of study.
• Manage study team and/or CRO to ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
• Serve as escalation point for vendor relationship management.
• 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; drive to issue resolution.
• Lead and/or collaborate in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials, case report forms, study plans, and clinical study reports. Manage completion of these deliverables to ensure timelines are upheld. Ensure study documents are updated as needed throughout the trial.
• Partner with internal contracts management to ensure review, finalization, and escalation as needed of site contracts and budgets.
• Plan site and country identification and selection in collaboration with internal partners.
• As appropriate per vendor/scope of work, manage and/or participate in vendor selection, specification development and management/oversight.
• Ensure management of the TMF set-up, ongoing quality review, and final reconciliation.
• 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.
• Lead study meetings including presenting as a subject matter expert as needed, ensuring agenda and meeting minutes are generated and distributed as needed.
• Manage the development/coordination of study training and study training materials for study team, investigational sites, and vendors.
• Contribute to oversight of the required country regulatory (e.g., Clinical Trial Application) and country/site IRB/IEC submissions/approvals/notifications.
• Ensure the collection of various study documents such as country/site insurance, clinical study report appendices, etc. is completed as needed.
• Manage Investigator Meeting coordination and planning.
• Lead and assist in training other Clinical Operations roles as needed.
• May oversee the activities of other Clinical Operations team members (may be applicable to Contractors/Consultants as needed).
• May have line management responsibilities, participate in resource planning, recruitment and talent development activities as needed.

Basic Requirements:

• BA/BS degree in a relevant discipline.
  
• 5+ years of experience in clinical drug development with at least one-year direct sponsor and/or CRO experience required.
  
• Early Phase Oncology Experience is required, radioligand therapy (RLT) preferred
  

Additional Preferences:

• Experience in managing global clinical trials.
• Knowledge and experience with ICH/GCP and regulatory guidelines/directives.
• Knowledge and experience with drug development processes.
• Experience managing a multi-functional team, including leadership skills and driving deliverables.
• Experience managing clinical research budgets.
• Ability to demonstrate analytical approach and anticipation of problems and independently provide solutions.
• 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.
• Ability to effectively prioritize assignments from multiple sources.
• Excellent organizational skills.
• Ability to proactively share information, ideas, input, and/or expertise to effectively collaborate with various team members and demonstrates concern for delivering high quality outcomes.
• Ability to respond flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
• Excellent people skills, strong professional diplomacy, and a positive attitude.
• Leadership skills and proven ability to foster team productivity and cohesiveness.
• Ability to be enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies.
• Strong communication skills, written and oral English proficiency.
• Strong proficiency in Microsoft Office suite and applications.
• Oncology and/or hematology experience highly preferred

Additional Information:

Physical Demands/Travel:
The physical demands of this job are consistent with an office environment.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position’s work environment is in an office.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Lilly currently anticipates that the base salary for this position could range from between $111,000 to $162,800 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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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