Senior Associate Job In Cork

Seeking a Therapeutic Area Associate to provide clinical laboratory support for assigned trials, coordinating vendor activities and facilitating research and resolution of clinical laboratory and diagnostic issues.

Eli Lilly Cork is a global healthcare leader with a diverse team of over 1,800 employees across 38 nationalities, delivering innovative solutions in various Business Service functions.

**Job Description**

The Therapeutic Area Associate will have early engagement with the study team, business and therapeutic partners on development of clinical laboratory, diagnostic and biomarker strategies at the trial level.

• 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 management plans.
• Partner with the Sourcing organization to follow the proper sourcing strategy for vendor assignment.

**Responsibilities**

• 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 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 management plans.
• Partner with the Sourcing organization to follow the proper sourcing strategy for vendor assignment.
• Project Management:
• Escalate issues as warranted to upper management.
• Proactively monitor 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.
• People Development:
• 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.

**Basic Requirements**

• Bachelor's degree in a science or related life sciences field.

**Additional Skills/Preferences**

• 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.

Eli Lilly Cork is committed to diversity, equity and inclusion, and is an equal opportunities employer.