Sr. Associate - 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:

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