Senior Associate / Manager - Clinical Laboratory Sciences
Eli Lilly
- Cork
- Permanent
- Full-time
- 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 clinical laboratory and diagnostic needs
- Provide and oversee clinical testing plans and study risk oversight as it pertains to clinical labs, diagnostic data reviews, and lab managements 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 improvement, and an external awareness and understanding
- Bachelor’s degree in a science or related life sciences field
- 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
- Negotiation skills
- Detail oriented
- Clinical trial experience preferred