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.
PURPOSE OF THE JOB:
- Responsible for the operations of the Clinical Research Unit (CRU) and cross functional interactions within the CRU, working closely with Manager, Pharmacy Operations and Manager, Patient Recruitment.
- Leads and influences cross-functional communications to ensure smooth delivery of clinical studies.
- Provides project management and study execution leadership in the delivery of clinical studies.
CORE JOB TASK
CRU Operations
- Work closely with LCCP Management to align on the management of CRU’s study portfolio
- Drives the integration of CRU cross-functional activities to deliver study requirements.
- Provides operational leadership to CRU study teams, through participation in various meetings such as protocol review meetings, study execution meetings and liaising with sponsor and CRO team to resolve emerging study execution issues.
- Provides consistency in study execution in the CRU by:
- Serving as Subject Matter Expert and a resource of knowledge for CRU operational processes, local IRB and regulatory requirements.
- Providing input on study design and operational feasibility during study planning.
- Working with sponsor and site project teams to ensure consistency in responses to IRB.
- Working with scheduler and project specialist to ensure development of realistic project milestones and deliverables.
- Influences study teams to maintain proper documentation of key decisions, actions and meeting minutes.
- Identify and share learning opportunities or process improvements with teams to improve effectiveness of study execution.
- Work with cross functional teams in root cause analysis and identification of appropriate corrective and preventive actions (CAPAs). Perform post implementation assessment to ensure CAPAs are effectively implemented
- Provides input and ensures cross functional alignment in response to feasibility, RFI and RFP. Flag any CRU capability gaps that are identified during the RFI/RFP process and work with Management to develop a remediation plan.
- Maintains a database of clinical operational information relevant to the CRU.
- Oversee equipment life cycle management to ensure equipment are maintained to support CRU capabilities. Assume System Owner role where appropriate.
- Oversees IRB submissions and ensure submission timelines are adhered to.
- Ensure remedial initiatives are being carried out to address any quality issues identified during the quarterly quality governance meeting.
- Review CRU Standard Operating Procedures (SOPs) to ensure cross alignment and the SOPs remain current and appropriate.
Project Oversight and Project Management
- Leads and oversees CRU implementation of Lilly’s high priority clinical studies to ensure deliverables are met to support Lilly’s global portfolio decisions.
- Leads and oversees non-clinical projects that has moderate risk and moderate to high impact on the operational functioning and capability of the CRU in delivering clinical studies.
Regulatory Compliance
- Ensures studies are carried out in accordance to approved protocol, IRB requirements, Good Clinical Practice (GCP), Lilly global policies and local SOPs.
- Ensures personal and team’s compliance to required training.
- Maintains awareness of local and (where relevant) global regulatory requirements to ensure operational compliance.
Audits, Inspections and Self-Assessments
- Performs and/or supports self-assessments activities.
- Participates actively in all GQAAC audits and external regulatory inspections.
People Management
- Attracts, retains and develops a diverse workforce.
- Supervises, coaches and manages team members to effectively deliver results for the CRU.
- Defines individual and functional group objectives in alignment with LCCP priorities and Lilly objectives.
- Manages team members’ performance through the performance review process.
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 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.
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