Manager, Clinical Operations

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:

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, 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.

Manage and contribute to complex deliverables within study and 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 Manager/Senior Manager may have opportunities to lead creation/update/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 :

BA/BS Degree in a relevant discipline.

3 years of experience in the clinical trial environment required with direct site, sponsor and/or CRO experience preferred.

Additional Preferences:

Knowledge and experience with ICH/GCP and regulatory guidelines/directives.

Radioligand Therapy experience is preferred.

Knowledge and experience with drug development processes.

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.

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.

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., electronic system skills such as CTMS/ EDC/ IRT/ eTMF).

For oncology studies: Oncology and/or hematology experience 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.

To perform this job successfully, an individual must be able to perform the role and responsibilities 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 $96,000 to $140,800 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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