Req ID 40962 Title Associate-Clinical Laboratory Sciences City Indianapolis State / Province Indiana Country United States Region North America Company Overview 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 39,000 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.
Responsibilities Are you passionate about helping to improve the lives of patients? Do you strive for excellence, have respect for people and always exhibit integrity? Are you a team player with strong organizational, interpersonal and communication skills? Do you have experience working in clinical trials?
Our Clinical Laboratory Sciences group is looking for exceptional talent to join the team. You will have early engagement with the appropriate study team, business and therapeutic partners on the development of the clinical laboratory, diagnostic and biomarker strategies at the trial level. You will oversee vendor activities for assigned trials as well as facilitates research and resolution to any clinical laboratory and diagnostic issues or needs throughout the life of the trial. You will partner with the clinical team to provide input into the protocol development/design, develop and implement the integrated trial clinical laboratory plans and the review and monitoring of resultant data, ultimately providing high quality, combinable data in a cost-effective and timely fashion.
Portfolio Strategy, Planning and Delivery
Provide complete clinical laboratory, ECG, imaging, sample storage and other clinical diagnostic support as needed for assigned trial(s)
Provide expertise and consultation relating to clinical laboratory, ECG, imaging, sample storage and other diagnostic biomarkers, including assay development and validation.
Provide technical and logistical consultation regarding clinical laboratory, ECG, imaging, sample storage and other diagnostic biomarker issues and services
Provide input and review of the protocol related to clinicial laboratory and diagnostic needs
Provide and oversee clinical testing plans and study risk oversight as it pertains to clincial labs, diagnostic data reviews, and lab managments plans.
Partner with the Sourcing organization to follow the proper sourcing strategy for vendor assignment
Escalate issues as warranted to upper management
Proactively be monitoring for issues and trends
Drive clinical laboratory data completeness and accuracy within business systems
Drive communications to prospectively manage upcoming cross-functional activities, key milestones, and decisions as well as to proactively identify updates to schedule and partner with clinical to optimize timeline
Articulate the value of clinical laboratory solutions in terms of reliability, time, cost, quality and scalability
Monitor trial budgets and ensure FRAP compliance
Maintain accurate budget information and defined protocol testing in the Laboratory and Diagnostic tool
Maintain inspection readiness at all times by maintaining a complete eTMF at a trial level
Keep study team abreast of trial specific metrics and issues
Participate fully in the performance management process
Model the Lilly core values and behaviors
Provide peer coaching within the organization that fosters inclusion and innovation, continual improvemnt, and an external awareness and understanding
40962BR Basic Qualifications
Bachelor's degree in a science or related life sciences field
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Knowledge of clinical drug development
Prior laboratory experience or knowledge of laboratory testing
Strong self-management skills
Strong teamwork and interpersonal skills
Strong communication skills (verbal and written)
Conceptual understanding of information technology
Strong organizational skills
Clinical trial experience preferred
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. Here are a few of the recognitions Lilly has earned for creating an outstanding work environment:
Business Week magazine 50 Best Places to Launch a Career
Black Enterprise 2018 list of 50 Best Companies for Diversity
FORTUNE 50 Best Companies for Minorities
Human Right Campaign Corporate Equality Index - 100% score
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.
Eli Lilly And Company